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

Model Number 176657

Device Problems Difficult to Open or Close (2921); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

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 laparoscopic colectomy when performing the anastomosis, the jaws of the device did not close and the handle was jammed in open position.Another device was used to resolve the issue.There was no patient harm.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted damage to the instrument consistent with application over an obstruction.It was reported that the safety interlock deployed prior to all staples or clips firing and the jaws of the reload did not close at all.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the instrument was applied over an obstruction causing the jaws to misalign and damaged the component allowing the clips to eject from the device jaws unformed or malformed.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: firing a clip over another clip or other obstructions may result in bleeding and/or leakage and may damage the instrument jaws.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 10200611
• MDR Text Key: 196945015
• Report Number: 9612501-2020-00926
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: 10884521057869
• Combination Product (y/n): N
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J8K0330NX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR