MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP III; CLIP, IMPLANTABLE

Model Number 133650

Device Problems Fail-Safe Problem (2936); Mechanics Altered (2984)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

According to the reporter, during an open coronary artery bypass graft surgery, while clipping the inferior mesenteric artery (ima) branch, there were issues experienced with the loading or firing of the clips.The jaws closed but no clips were applied.The clip appliers still fired and the jaws close when the clips are out.Another small clip applier was applied on the same branch, but the clip did not deploy when fired.The surgeon then used a reusable single clip applier to resolve the issue.There was no patient injury.

Manufacturer Narrative

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

• Brand Name: PREMIUM SURGICLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13387937
• MDR Text Key: 284681625
• Report Number: 2647580-2022-00314
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: 10884521517394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P1J0979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/28/2022
• Date Device Manufactured: 09/17/2021
• 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
• Patient Sex: Male