MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON CIRCULAR STAPLER; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number ECS21A

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

Ethicon endoscopic curved intraluminal stapler (21mm) was used to staple the roux limb to existing stomach pouch.A leak test determined there was a hole in anastomosis.The section was removed and a new pouch was created using another stapler.The staplers were saved so the "donuts"(anastomosis rings) from stapler could be examined.Ethicon sales representative and myself looked at the rings and a video was taken of the process and the staplers were sent to risk management.Manufacturer response for endoscopic tissue approximation device, n/a (per site reporter).Our ethicon rep was on hand in the operating room.We'll follow-up with him in next day or so.

Event Description

Ethicon endoscopic curved intraluminal stapler (21mm) was used to staple the roux limb to existing stomach pouch.A leak test determined there was a hole in anastomosis.The section was removed and a new pouch was created using another stapler.The staplers were saved so the "donuts"(anastomosis rings) from stapler could be examined.Ethicon sales representative and myself looked at the rings and a video was taken of the process and the staplers were sent to risk management.Manufacturer response for endoscopic tissue approximation device, n/a (per site reporter).Our ethicon rep was on hand in the or.We'll follow-up with him in next day or so.

• Brand Name: ETHICON CIRCULAR STAPLER
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 7467949
• MDR Text Key: 106716642
• Report Number: 7467949
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10705036003489
• UDI-Public: (01)10705036003489
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: ECS21A
• Device Catalogue Number: ECS21A
• Device Lot Number: P94342
• Other Device ID Number: (17)220930(10)P94342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• 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
• Patient Age: 17885 DA
• Patient Weight: 173