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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC 1 PROXIMATE STAPLER STAPLER, SURGICAL

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ETHICON ENDO-SURGERY, LLC 1 PROXIMATE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number REF: TLC75
Device Problem Failure to Fire (2610)
Patient Problem Rectal Anastomotic Leakage (4482)
Event Date 02/04/2021
Event Type  Injury  
Event Description

Once closed, stapler wouldn't fire, resulting in damaged bowel and need for further colon resection (damaged the anastomosis site). Fda safety report id # (b)(4).

 
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Brand Name1 PROXIMATE STAPLER
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
MDR Report Key11307351
MDR Text Key231583209
Report NumberMW5099318
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREF: TLC75
Device LOT NumberU40T8K
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/09/2021 Patient Sequence Number: 1
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