MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP II; CLIP, IMPLANTABLE

Model Number 176657

Device Problems Misfire (2532); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 06/01/2020

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 clip applier was inserted into the patient.The doctor fired the clip, but the applier misfired, jammed, and the jaws were unable to close.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10525423
• MDR Text Key: 206725517
• Report Number: 9612501-2020-01300
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: 10884521057869
• 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 faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2020

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: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J0E0120NY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2020
• Initial Date FDA Received: 09/11/2020
• Date Device Manufactured: 05/06/2020
• 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: 87 YR