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

Model Number 176630

Device Problem Device Slipped (1584)

Patient Problems Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, after laparoscopic cholecystectomy procedure, the patient bleed out because two clips fell of the arteria cystica and lay in the liver bed.There was a second operation to stop the bleeding where in 4 packages of blood transfusion (1.3 liter all together) was done.The laparotomy of the reoperation caused a tissue damage, extended incision and the event lead to extended hospital stay.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of four device.The instruments were received sealed with the full complement of sixteen clips each.No visual abnormalities were observed with the instruments.The instruments were applied to appropriate test media for functional evaluations.The instruments were found to cycle without binding.Clips advanced into the jaws, formed properly, and were held securely in place after full formations were achieved and the firing handles were released.In addition, when the cartridges were empty, the interlocks 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 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: 9203166
• MDR Text Key: 162902118
• Report Number: 9612501-2019-02011
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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: 03/31/2022
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9D0095Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention