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

Model Number 133650

Device Problem Mechanics Altered (2984)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/23/2021

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 an open breast removal, when a vessel was set down, there was no clip in the branch and it cut through the vessel.The incision was extended for more than 1 inch.There severed vessel was sewn back together.

• 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: 12601793
• MDR Text Key: 276897611
• Report Number: 2647580-2021-03433
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: 10884521517394
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K142869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: No
• 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