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

Model Number 176657

Device Problems Break (1069); Mechanics Altered (2984); Noise, Audible (3273)

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

Event Date 08/22/2018

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 prostatectomy, when the surgeon needed to clip a vessel to release the prostate, the surgeon used the first clip applier, there was a snap at first use then it did not clip.When he used the second clip applier to replace the first defected one, the clip closes badly / the yellow safety is not fixed on the device.So they used a third clip applier at the request of the surgeon.There was no problem at the third time.No patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with eight remaining clips.No visual abnormalities were observed with the instrument.The instrument was applied to appropriate test media for functional evaluation.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.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 II
• 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: 7886586
• MDR Text Key: 120594067
• Report Number: 9612501-2018-01663
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: 10884521057869
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J8D2289CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1