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

Model Number 134048

Device Problems Mechanical Problem (1384); Mechanics Altered (2984)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a cephalic duodenopancreatectomy, the clips on the five clip appliers engaged at an angle in the jaws of the clamp, the clips jumped and did not close completely.The hemorrhage was not able to be controlled by the clips, which resulted into a surgical intervention using ligature and wire.The hospital stay was extended by 8 days.It was noted that there were two other operations following the first intervention.The event resulted to post operative sepsis, hemorrhagic complications on pancreatic fistula and the patient was transferred to the intensive care unit.The patient died due to false aneurysm following a pancreatic fistula unrelated to the medical device.

Manufacturer Narrative

Additional information: b2, g3, h1, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted an improperly loaded clip.During functional testing a clip misloaded during the firing cycle.A manufacturing fault was identified during product analysis.Carrier misalignment causing clips to misload.Improvements have been implemented to mitigate this condition.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
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 11262011
• MDR Text Key: 229738370
• Report Number: 2647580-2021-00392
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057555
• UDI-Public: 10884521057555
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134048
• Device Catalogue Number: 134048
• Device Lot Number: P9H0184Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 95