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

Model Number ECS29A

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2020

Event Type  malfunction  

Event Description

When the stapler was fired, it did not make any audible noise that it had engaged and fired.The stapler was fired a second time before releasing and at that time found the stapler did fire correctly but not audible feedback again with the second firing.

• Brand Name: N/A
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11154064
• MDR Text Key: 226242372
• Report Number: 11154064
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10705036003502
• UDI-Public: (01)10705036003502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECS29A
• Device Catalogue Number: ECS29A
• Device Lot Number: T94L2A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1