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

Model Number	134048
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: egia45avm, egia45avm egia 45 artic vasc med sulu (lot#n3e0402y); eeaorvil25a, eeaorvil25a eea orvil 25mm automaticdv (lot#n3a0093y); egia60axt, egia60axt egia60 artic extra thicksulu (lot#n3c0660y); egiaustnd, egiaustnd endogia ultra univ std stap (lot#p2h0531); egiaustnd, egiaustnd endogia ultra univ std stap ( lot#p2h0531); unknown eea, unknown eea.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.
Event or Problem Description
According to the reporter, during a laparoscopic esophageal cancer procedure, the surgeon was unable to squeeze the handle after pressing the green button.The issue occurred in two sets of handles and reloads.The clip applier was able to fire.However, the clip was malformed.The orvil anvil was difficult to load into the device.New devices were used to resolve the issue.The same circular handle was used with the new orvil anvil.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
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18680369
• Report Number: 2647580-2024-00738
• Device Sequence Number: 17698053
• Product Code: FZP
• UDI-Device Identifier: 10884521057555
• UDI-Public: 10884521057555
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K143644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2024

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 Model Number: 134048
• Device Catalogue Number: 134048
• Device Lot Number: P2D0140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/09/2024
• Date Device Manufactured: 04/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H10
• Patient Sex: Female
• Patient Weight: 52 KG