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

Model Number 176620

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Fail-Safe Problem (2936)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

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 a procedure, the first clip was malformed and got stuck at the vessel and the jaws.The surgeon had to dislodge the clip that was stuck at the vessel without damaging the device.After the clip was removed, the handle of the clip applier was blocked as if there was no more clip available, although only one clip was used.Another device was opened to complete the case.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11824864
• MDR Text Key: 251990240
• Report Number: 3003139373-2021-00063
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057876
• UDI-Public: 10884521057876
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2021

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: 176620
• Device Catalogue Number: 176620
• Device Lot Number: T9K107X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/14/2021
• Date Device Manufactured: 10/30/2019
• 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