CONMED CORPORATION ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM; FORCEPS, GENERAL & PLASTIC SURGERY
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Catalog Number 11.1002 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation of the returned 11.1002 device found the device discolored with worn etching and the tip worn/damaged.The manufacturing documents from the device history record were not reviewed due to the device having been in the field for more than 12 months.The service history was reviewed and no prior data was found.(b)(4).Per the instructions for use, the user is advised the following: precautions: inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instrument after use to ensure it has not been damaged.Instrument is designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper technique for use.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The customer reported that the device, 11.1002, had the bottom jaw break off the device.A good faith effort was performed to gain more information; however, no response has been received from the reporter to date.There was no report of injury to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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