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

Model Number 176630B

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

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 laparoscopic low anterior resection surgery, the device was used for vessel.The clips released from the jaws were malformed and fell into the cavity but all were retrieved.The procedure was completed with another device.No patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied four remaining clips.Five malformed clips, two properly formed clips, and one partially formed clip were received.Microscopic evaluation of the malformed clips noted a clip over clip application.Functionally; the instrument was applied to appropriate test media.The clips advanced into the jaws, formed properly, and were held securely in place after full formation was achieved and the firing handle was released.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the observed condition may occur if an attempt is made to apply a clip over a fully formed clip or obstruction.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO CLIP III
• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 7606745
• MDR Text Key: 111305335
• Report Number: 9612501-2018-01110
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20884521047263
• UDI-Public: 20884521047263
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 176630B
• Device Catalogue Number: 176630B
• Device Lot Number: J8A2311X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• 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