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

Model Number 176630

Device Problems Image Display Error/Artifact (1304); Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the handle was able to squeeze, but clips would not load and the clip counter counts the fire with no clips.There was no patient involvement.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9222083
• MDR Text Key: 182982555
• Report Number: 9612501-2019-02053
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• 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