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

Model Number 170004

Device Problems Entrapment of Device (1212); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12728693
• MDR Text Key: 279320316
• Report Number: 1219930-2021-04549
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521126906
• UDI-Public: 20884521126906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 170004
• Device Catalogue Number: 170004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1