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

Model Number	134046
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the photo depicts the distal end of the instrument with a misloaded clip in the jaws.It was reported that the safety interlock deployed prior to all staples firing.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open barco (head and neck) procedure for cancer, no clips were able to be fired from the device, the clips were stuck.A new device was used to resolve the issue and complete the case.There was no patient injury.

• Brand Name: PREMIUM SURGICLIP
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 11048181
• Report Number: 2647580-2020-04119
• Device Sequence Number: 2691969
• Product Code: FZP
• UDI-Device Identifier: 10884521057548
• UDI-Public: 10884521057548
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K143644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 134046
• Device Catalogue Number: 134046
• Device Lot Number: P9C1336Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1