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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON 75 MM LINEAR CUTTER

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ETHICON 75 MM LINEAR CUTTER Back to Search Results
Model Number TLC75
Device Problems Failure to Cycle (1142); Misfire (2532); Failure to Cut (2587)
Patient Problem Tissue Damage (2104)
Event Date 08/24/2018
Event Type  Injury  
Event Description

Surgeon used linear cutter to cut through colon. The device misfired and cut partially and then was unable to be removed from the organ. The surgeon was required to cut out additional portion of bowel to remove the stapler. He then had to spend extended time in the operating room. Devices will be returned only if manufacturers provide prepaid shipping, packaging as per dot, or pick the item up. The details in the report is the extent to which we identify medications involved or pt contact.

 
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Brand Name75 MM LINEAR CUTTER
Type of Device75 MM LINEAR CUTTER
Manufacturer (Section D)
ETHICON
MDR Report Key7870016
MDR Text Key120241402
Report Number7870016
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 NOT APPLICABLE
Type of Report Initial
Report Date 08/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTLC75
Device LOT NumberR40G23
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2018
Distributor Facility Aware Date08/24/2018
Event Location Hospital
Date Report TO Manufacturer08/31/2018
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/04/2018 Patient Sequence Number: 1
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