MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO CLIP; CLIP, IMPLANTABLE

Model Number 176620

Device Problems Precipitate in Device or Device Ingredient (1478); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic procedure, upon closing a vessel, when the clip was released a black deposit fell from the insert onto the patient's tissue.

Event Description

According to the reporter, during laparoscopic procedure, upon closing a vessel, when the clip was released a black deposit that look like grease fell from the gap between the jaws of clip onto the patient's tissue.The surgeon used another device to complete the case.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Functional testing found the instrument cycled 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.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.In addition; no abnormalities were observed.It was reported that a component disengaged into cavity, and there was excessive lubricant.A related device issue could not be confirmed.The most likely root cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.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): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10114672
• MDR Text Key: 193647017
• Report Number: 1219930-2020-02246
• 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,Followup
• Report Date: 08/26/2020

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: 12/31/2021
• Device Model Number: 176620
• Device Catalogue Number: 176620
• Device Lot Number: N6M0516CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 08/25/2020
• Supplement Dates FDA Received: 07/03/2020; 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other