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

Model Number 176630

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, the device failed to function properly, it worked properly on the start but, when the device re-inserted to the port it was found to have widened jaws which caused difficulty of the device to insertion into the port.Upon further inspection the device will eject clips but the clips would not close.They then used another device to resolve the issue.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially fired with nine clips remaining.Visual inspection of the instrument noted that one of the jaw legs was out of position.The cam on the jaw leg was not aligned with the driver.Functionally, the jaw leg was reset by aligning the cam with the driver.The instrument was then applied to test media.The remaining clips loaded into the jaws, formed properly, released from the jaws and remained securely attached to test media.The interlock engaged after all clips were dispensed 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.Replication of the disengaged jaw cam condition may occur when one of the jaws legs gets forcefully pulled outward away from the center line of the shaft.The noted jaw cam disengagement impedes functionality of the jaws, possibly resulting in clip malformation and/or difficulty removing the instrument from a trocar.The root cause of the observed damage was misuse of the product which caused or con tributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8529966
• MDR Text Key: 142464445
• Report Number: 9612501-2019-00816
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20884521057859
• UDI-Public: 20884521057859
• Combination Product (y/n): N
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J6J2000X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 69