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

Model Number 134051

Device Problems No Device Output (1435); Mechanics Altered (2984); Noise, Audible (3273)

Patient Problems Perforation of Vessels (2135); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

According to the reporter, during a procedure, the surgeon was able to squeeze the handle, the 2 clip appliers failed and misfired on tissue, did not have an audible or tactile indicator to inform the user that the clip has been deployed and fired on tissue, and no indicator to lock out the clip applier when it was out of clips.The doctor noted there was tissue damage like tissue tearing or avulsion of the small vessels.The doctor re-requested the use of a different clip applier from another manufacturer to resolve the issue.

Manufacturer Narrative

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

• Brand Name: PREMIUM SURGICLIP II
• 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: 13397144
• MDR Text Key: 284719204
• Report Number: 2647580-2022-00330
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057562
• UDI-Public: 10884521057562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143644
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134051
• Device Catalogue Number: 134051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• 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 Outcome(s): Other