MAUDE Adverse Event Report: CELESTICA DE MONTERREY S.A. DE C.V. ENDO CLIP; CLIP, IMPLANTABLE

Model Number 176620

Device Problems Failure to Align (2522); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

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 laparoscopic cholecystectomy, when attempting to clip the cystic artery, the jaws would not allow the clip to load.Red empty window showing on end of applier after first attempt to fire a clip.On closer inspection, the surgeon noticed that the jaws were misaligned.Another clip applier was opened and used to complete the case.There was no patient injury.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted presence of clips in the instrument tube.The red indicator was visible in the window and the pusher bar was observed to be buckled.It was reported that the clips did not load properly into the jaws as expected and the jaws were misaligned.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The issue of the buckled pusher bar condition may occur under the following conditions: if the load indicator printed on the distal end of the instrument shaft has not cleared the distal end of the cannula and the instrument is fired.If a heavy load is applied to the side of the jaw which partially closes it during the clip loading process.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: attempts to load clips into the device jaw without full clearance of the trocar sleeve, and full visibility to the word ¿load¿ can result in device failure, malfunction, and/or malformed clips.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
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• MDR Report Key: 11361149
• MDR Text Key: 233793945
• Report Number: 3003139373-2021-00030
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057876
• UDI-Public: 10884521057876
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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 Model Number: 176620
• Device Catalogue Number: 176620
• Device Lot Number: T9L081X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1