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

Model Number 134053

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted visual inspection noted that four clips were received.One twisted clip, one malformed clip, and two properly formed clips.It was also found that the instrument was sealed with the full complement of thirty clips and the ratchet function was engaged.Malformed clips were provided and the handle was noted to be out of position.The condition was replicated by partial compression of the handle.Functionally, the ratchet function was disengaged.The instrument was first tested to be fired once in air so that the clip formation could be observed.The remaining clips were fired on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and returned to the open position.Each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaws from approximating.It was reported that the clips did not close completely and clip legs were malformed, crossed like a scissor.The physical appearance of the product was different than expected.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the distal end of the device was subjected to excessive manipulation during application of the instrument.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not excessively twist or torque the jaws.Excessive twisting or torqueing the jaws may dislodge clip from the jaws or cause clip malformation after jaw closure.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.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 Description

According to the reporter, during open parathyroidectomy, at dissection, the clips would not close completely.Some clips had one leg longer than the other.Also, some clip legs completely crossed.Another clip applier was used to resolve the issue in order to complete the case.There was no patient injury.

• 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
• 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: 16845463
• MDR Text Key: 314316713
• Report Number: 2647580-2023-01827
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: 10884521057579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P2M0479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1