The lot number for the two reported malfunctions was provided, and lot history reviews were performed.The devices for both malfunctions were not returned for evaluation; however, medical records were provided and reviewed.For one of the two reported malfunctions, the investigation is confirmed for perforation and tilt.The investigation for the second malfunction is confirmed for perforation; however, is inconclusive for tilt.Based on the information provided, the definitive root cause is unknown.The devices are labeled for single use.
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