(b)(4).Manufacturing site evaluation: we received a pair of scissors for investigation decontaminated.The instrument is in mint condition, but the tips are bent.Visual investigation: the tips of both blades are bent in the same direction, most likely caused by a drop.Therefore, the cutting performance is no longer according to the specifications.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most likely related to insufficient usage.Rationale: the damage to the working end was most likely caused by a drop, e.G.During handling or reprocessing.According to the instructions for use (ifu), the working ends need to be protected: "packaging - appropriately protect products with fine working tips".
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It was reported that there was an issue with the micro scissors.During cerebro-neuro procedure, the micro-scissors did not cut.It was noted during the first use of the 2 scissors, and there was some tearing of tissue.The first scissor also had a screw loosen.No intervention was required and there was no surgical delay reported.The patient was not harmed and there were no injuries or consequences.Additional information was not provided.Associated medwatches: (2 scissors reported separately).
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