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

Model Number 134051

Device Problem Material Deformation (2976)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during mediastinal mass excision on the patient heart, when the surgeon fired the device's the clip crossed and instead of occluding the blood vessel, the device ligate the vessel.To resolve the issue the surgeon then used another device from other manufacturer and that satisfied the bleeding vessel.

• 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: 12425637
• MDR Text Key: 269904282
• Report Number: 2647580-2021-03014
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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
• Device Lot Number: P0M1904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Date Device Manufactured: 12/22/2020
• 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): Required Intervention