MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC N/A; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number ECS29A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Excessive Tear Production (2235)

Event Date 01/24/2018

Event Type  Injury  

Event Description

The pin of the eea stapling device was advanced through the wall of the rectum anterior to the staple line.The anvil within the colon was then fitted onto the pin of the eea stapling device and the device was closed under direct vision.The eea stapling device was fired.However, upon removal of the eea stapling device, it started tearing the bowel at the anastomosis.At this point, the eea stapling device was opened and was examined.It seemed that the eea stapling device had not divided the colon wall circumferentially and it was torn.The anvil of the eea stapling device was removed from the eea device and the wall of the colon was examined.Part of the circular incision at the anastomosis was not complete, about 20% of the wall was still intact.This was cut sharply and the eea stapling device was removed.

• Brand Name: N/A
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; ml #132; cincinnati OH 45242
• MDR Report Key: 7361439
• MDR Text Key: 103187769
• Report Number: 7361439
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10705036003502
• UDI-Public: (01)10705036003502
• 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: 01/26/2018,03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ECS29A
• Device Catalogue Number: ECS29A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 120