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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LINEAR CUTTER SURGICAL STAPLER - TLC75

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ETHICON ENDO-SURGERY, LLC LINEAR CUTTER SURGICAL STAPLER - TLC75 Back to Search Results
Model Number TLC75
Device Problems Positioning Failure (1158); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2016
Event Type  Malfunction  
Event Description

Surgical stapler misfire, with an open patient during a colon resection, in the operating room. Details: during surgery, after using the tlc75 (75mm linear cutter), it was reloaded. When the surgeon attempted to use the stapler, it misfired. A couple of the staples were partially fired while the remainder were intact. None of the staples were fully deployed into the patient, so no risk of leaving a loose staple in the colon. The device was removed from the field and bagged up for further study. A new tlc75 was given to the field and used without incident.

 
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Brand NameLINEAR CUTTER
Type of DeviceSURGICAL STAPLER - TLC75
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
MDR Report Key6050571
MDR Text Key58177061
Report Number6050571
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date04/30/2021
Device MODEL NumberTLC75
Device Catalogue NumberTLC75
Device LOT NumberN4LJOH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2016
Event Location Hospital
Date Report TO Manufacturer10/07/2016
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

Patient TREATMENT DATA
Date Received: 10/24/2016 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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