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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, ASSEMBLED IN MEXICO MADE IN PUERTO RICO ETHICON ECHELON FLEX POWERED PLUS STAPLER

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ETHICON, ASSEMBLED IN MEXICO MADE IN PUERTO RICO ETHICON ECHELON FLEX POWERED PLUS STAPLER Back to Search Results
Model Number 60 PCEE60A
Device Problems Failure to Fire (2610); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2019
Event Type  Injury  
Event Description

Ethicon 60 pcee60a would not fire after being clamped onto the lung tissue. Stapler would not open to be removed from lung tissue. This required a second same type stapler to be used to complete the procedure. All attempts to unlock or release stapler failed. Report submitted by the accreditation licensing dept for (b)(6) memorial hosp, (b)(6), msn, rn, phn, hacp, area director accreditation licensing, (b)(6). We have the device sequestered; awaiting direction, please.

 
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Brand NameETHICON ECHELON FLEX POWERED PLUS STAPLER
Type of DeviceETHICON ECHELON FLEX POWERED PLUS STAPLER
Manufacturer (Section D)
ETHICON, ASSEMBLED IN MEXICO MADE IN PUERTO RICO
MDR Report Key8874614
MDR Text Key153831438
Report Number8874614
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
Type of Report Initial
Report Date 08/06/2019,07/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number60 PCEE60A
Device Catalogue Number60 PCEE60A
Device LOT NumberT9262Z
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2019
Distributor Facility Aware Date06/06/2019
Event Location Hospital
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: 08/05/2019 Patient Sequence Number: 1
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