It was reported that during a subacromial decompression, the tip of the scope was cracked.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H3, h6 : the device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.A device labeling/ instructions for use review was performed and indicated instructions for use includes recommendations, instructions and precautionary statements for proper use of the product.The risk level based on severity and final occurrence is acceptable.Factors that are known to contribute to the alleged fault/failure may be shipping damage or contact with another source.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
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