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

Model Number 176625

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy procedure, while on cystic duct closure, the trigger system of the device was working but the clips did not close properly thus not being able to close the cystic duct properly resulting to bile leakage into the abdomen.The leaked bile was cleared out of the abdomen by being flushed and suctioned then patient was treated with antibiotics.Another device was used to complete the case.

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.Note that the information for use brochure which accompanies each product shipment cautions the user as follows: firing a clip over another clip or other obstructions may result in bleeding and/or leakage and may damage the instrument jaws.Also, avoid excessive twisting of the jaws or tissue manipulation when firing the instrument.Deflecting the jaws and/or shaft during firing may result in an improperly formed clip and possible bleeding and/or leakage.A review of the device history record indicates this product was 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
• 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: 9148127
• MDR Text Key: 161333858
• Report Number: 9612501-2019-01874
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J8L1789NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other