MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC POWERED ENDOPATH STAPLER; STAPLER, SURGICAL

Catalog Number PCE60A

Device Problems Failure to Fire (2610); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2016

Event Type  malfunction  

Event Description

During an extensive abdominal surgery, after clamping onto tissue, the stapler would not fire.The device also would not open - used the "emergency release" lever to open the jaws of the stapler.The patient was not injured.

• Brand Name: POWERED ENDOPATH STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 5670943
• MDR Text Key: 45659488
• Report Number: 5670943
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: PCE60A
• Device Lot Number: N9028L
• Other Device ID Number: CE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR