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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION CONMED/LINVATEC PASSER

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CONMED CORPORATION CONMED/LINVATEC PASSER Back to Search Results
Model Number C6382
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2019
Event Type  malfunction  
Event Description
Using suture hook, disposable 60 right - with arthroscopic rotator cuff repair surgery. Tip of hook broke off and was retrieved per surgical team. No issues with care provided.
 
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Brand NameCONMED/LINVATEC
Type of DevicePASSER
Manufacturer (Section D)
CONMED CORPORATION
525 french rd
utica NY 13502
MDR Report Key8616528
MDR Text Key145277487
Report Number8616528
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC6382
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/14/2019
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer05/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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