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 Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

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 sigmoidectomy, device was able to be used without problem until the second firing but at the third firing, though the handle was squeezed the clip was not loaded.It was also noted that when the handle was squeezed, the remaining times of the counter display decreased.The procedure was completed with another device.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with eleven remaining clips.No visual abnormalities were observed with the instrument.The instrument was applied to appropriate test media for functional e valuation.The instrument was found to cycle without binding.Clips advanced into the jaws, formed properly, and were held securely in place after full formation was achieved and the firing handle was released.In addition, when the cartridge was empty, the interlock engaged to prevent the jaws from approximating.The clip counter was no longer active upon receipt of the instrument.The handle was disassembled for visualization of internal components.A representative battery was assembled onto the subject clip counter for further evaluation.The returned counter indexed properly from 16 to 00 without issue multiple times.Note that the clip counter indexes according to handle actuation of the trigger, not by the clip feed mechanism.If the instrument handle (trigger) is actuated partially and is manipulated while remaining on the ratchet mechanism, this may result in the clip counter indexing without loading and deployment of clips.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 9353909
• MDR Text Key: 167412463
• Report Number: 9612501-2019-02250
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9C2948Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1