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

Model Number 176625

Device Problems Mechanics Altered (2984); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, on the third firing of a laparoscopic cholecystectomy, a crack sound was heard and firing was unavailable.Another product was used to complete the case.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 five remaining clips.During functional evaluation, it was observed that the jaws would not close upon actuation of the handle.The instrument body was removed from the shaft and disassembled for visualization of internal components.It was observed that the firing handle linkage was forced through the channel tube lugs, suggesting that the instrument had been fired through the safety interlock.Due to the noted damage, further functional testing of the instrument could not be performed.In addition; the interlock mechanism was triggered as a result of rapidly actuating the handles of the device and or forcing the device, this renders the device inoperable and poses no harm to the patient.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 this condition may occur when an attempt is made to fire the instrument without first loading a clip by using the trigger.The safety interlock feature is designed to prevent the jaws from closing on a vessel in the absence of a loaded clip.If an attempt is made to forcibly fire the instrument while engaged in interlock, the lugs are designed to break as noted and the interlock feature continues to function as intended.No further actions have been deemed necessary at this time.The root cause of the observed damage was due to the product not being used as intended which caused or contributed 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
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 9102214
• MDR Text Key: 159657166
• Report Number: 9612501-2019-01789
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20884521057842
• UDI-Public: 20884521057842
• Combination Product (y/n): N
• PMA/PMN Number: K954435
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J8H2419NX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1