During preparation for a medical procedure, the hospital technician noticed that the mid-shaft of the benchmark 6f 071 delivery catheter (benchmark) was crushed upon removal from packaging.The damage to the benchmark was found prior to use and, therefore, the benchmark was not used in the procedure.The procedure was completed using a new benchmark.
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Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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