MAUDE Adverse Event Report: CELESTICA DE MONTERREY S.A. DE C.V. ENDO CLIP; CLIP, IMPLANTABLE

Model Number 176620

Device Problems Mechanical Problem (1384); Device Slipped (1584)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, clip applier did not deploy nor secure clips for ligation of vessel.Multiple clips were fired to the vessel and each one popped off and didn't close correctly on the vessel.Surgeon used another alternative form of ligation to resolve the issue.No patient injury.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer (Section G): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13115253
• MDR Text Key: 284113630
• Report Number: 3003139373-2021-00271
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057876
• UDI-Public: 10884521057876
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176620
• Device Catalogue Number: 176620
• Device Lot Number: T0F228X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Date Device Manufactured: 06/27/2020
• 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 Age: 35 YR
• Patient Sex: Female