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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER 60MM 340MM SHAFT STAPLER

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ETHICON POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER 60MM 340MM SHAFT STAPLER Back to Search Results
Catalog Number PSEE60A
Device Problem Failure to Cut (2587)
Patient Problem No Information (3190)
Event Date 03/13/2017
Event Type  Malfunction  
Event Description

Stapler sealed but did not cut. Stapler removed, new stapler opened. Stapler that misfunctioned information as follows: powered plus articulating endoscopic linear cutter 60mm 340mm shaft length ref psee60a, lot n93n54, expiration (b)(6t) 2019.

 
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Brand NamePOWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER 60MM 340MM SHAFT
Type of DeviceSTAPLER
Manufacturer (Section D)
ETHICON
MDR Report Key6412644
MDR Text Key70358486
Report NumberMW5068510
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device Catalogue NumberPSEE60A
Device LOT NumberN93N54
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2017
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/15/2017 Patient Sequence Number: 1
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