MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP II; CLIP, IMPLANTABLE

Model Number 134051

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, on an open left breast ultrasound guided lumpectomy, the device was used for clipping the specimen that was outside of the patient¿s body after it was removed.In the x-ray taken of the specimen, the surgeon noticed that a lot of the clips were malformed.The surgeon continued to use the device throughout the case with no issues.There was no patient injury.

Manufacturer Narrative

Additional information: d8, d9(return date), g3, g4 (pma/510(k)#,h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection of the returned photo noted six malformed clips.The instrument was fully applied with the interlock engaged.The distal end of the channel cover was intact.Microscopic inspection of the jaw revealed acceptable jaw co-planarity.Functionally, the instrument was received fully fired and the interlock was properly engaged and prevented the jaws from approximating.It was reported that the clips did not close completely and were malformed.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue of the malformed clips condition may occur if the distal end of the device is subjected to excessive manipulation.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: PREMIUM SURGICLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 10786867
• MDR Text Key: 214619473
• Report Number: 2647580-2020-03688
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057562
• UDI-Public: 10884521057562
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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 Model Number: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P0H0169Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1