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

Model Number 176630B

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Failure to Align (2522)

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

Event Date 03/16/2018

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 a laparoscopic cholecystectomy, the surgeon was unable to squeeze the handle, the clips were unable to load properly into the jaws and the jaws did not lock onto the tissue.The tip hung out, preventing it from removing through the 5mm trocar and had to be removed with the trocar.The instrument lost several clips outside of the patient.A new clip was used to completed the case.There was no patient injury in this event.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of four photos and one device.The first and second photos depict the cams on one of the jaw legs were disengaged from the drivers.The third and fourth photos depict unformed clips and a partially formed clip next to the jaws of the instrument with cams on one of the jaw legs disengaged from the drivers.The instrument was received partially fired with five 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.The tissue stop was disengaged.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.A review of the device history record indicates the product was 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.Replication of the disengaged tissue stop may occur when the distal end of the instrument is subjected to excessive manipulation.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.

Event Description

According to the reporter, during a laparoscopic cholecystectomy procedure, the surgeon was unable to squeeze the handle, the clips were unable to load properly into the jaws and the jaws did not lock onto the tissue.The tip hung out, preventing it from removing through the 5mm trocar and had to be removed with the trocar.The clips fall from the jaws of the device.The instrument lost several clips outside of the patient.A new clip was used to completed the case.There was no patient injury in this event.

Manufacturer Narrative

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: 7386184
• MDR Text Key: 103987093
• Report Number: 9612501-2018-00684
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20884521047263
• UDI-Public: 20884521047263
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 176630B
• Device Catalogue Number: 176630B
• Device Lot Number: J7E2816X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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