Stryker Gets 483 Over Complaints, Reporting

Stryker Endoscopy received a Form 483 from the FDA after a reporting failure and issues with complaint handling.

The San Jose, Calif., company failed to identify corrective actions after it reviewed at least 31 complaints, some of which were classified as “misuse.” The misuse included cutting the suction tube of suction probes during surgery, causing a malfunction. This could contribute to permanent impairment as the result of unintended ablation or coagulation of healthy tissue, the form says.

Stryker’s log of corrections and removals since its last inspection showed a 2013 removal related to mounts for cameras used to examine internal tissue. The action was not reported in writing to the FDA, according to the form.

About 469 complaints reported related issues, such as unexpected tints to pictures. The company’s medical risk assessment confirmed the hazard as “incomplete/unclear signal output: incorrect or poor color” and the corresponding harms as soft tissue injury and conversion to open surgery. The severity of harm was recorded as temporary or reversible and intervention required, respectively, the form says.

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