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

Model Number 134051

Device Problem Mechanics Altered (2984)

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

Event Date 11/25/2021

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 left mastectomy and breast construction, upon firing, the first clip did not engage and the device jammed.Another clip applier was used to complete the case.There was no patient injury.

• 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: 12977313
• MDR Text Key: 282059623
• Report Number: 2647580-2021-04205
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057562
• UDI-Public: 10884521057562
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

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: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P1G0746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/10/2021
• Date Device Manufactured: 07/09/2021
• 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: Female