MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SOFSILK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	170004
Medical Device Problem Codes	Entrapment of Device (1212); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic gastric bypass while being applied on the stomach, the device was difficult to toggle, load, unload, and the tissue kept getting stuck in the jaws while toggling the needle between jaws.The surgeon continued to use the device with some difficulty but was able to finish the procedure.There was no patient injury.

• Brand Name: SOFSILK
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 12728693
• Report Number: 1219930-2021-04549
• Device Sequence Number: 11902159
• Product Code: OCW
• UDI-Device Identifier: 20884521126906
• UDI-Public: 20884521126906
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 170004
• Device Catalogue Number: 170004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1