MAUDE Adverse Event Report: CONMED UTICA REFLEX ELC,20M/L CLPS,10/11MM; APPLIER, HEMOSTATIC CLIP

Model Number	530
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of their customer that the 530, reflex elc, 20m/l clps, 10/11mm, was being used during an unknown procedure on (b)(6) 2022, when it was reported, ¿when it is clipped several times from the start of use, it is frequently twisted and clipped, making it unusable.¿ there was no report of medical intervention or hospitalization for the patient.There was no patient or user impact.The procedure was completed with another unknown device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the 530, reflex elc,20m/l clps,10/11mm, was being used during an unknown procedure on 14oct22, when it was reported, ¿when it is clipped several times from the start of use, it is frequently twisted and clipped, making it unusable.¿ there was no report of medical intervention or hospitalization for the patient.There was no patient or user impact.The procedure was completed with another unknown device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
To date, the device has not been returned but photographic evidence was provided that confirmed the reported problem.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of two (2) complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 48 reports, regarding 88 devices, for this device family and failure mode.During this same time frame 18,288 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.005.Per the instructions for use, the user is advised the following: squeeze the trigger firmly until it stops.As the trigger is closed, the clip is held by the jaws and closes around the tissue or vessel.Note: failure to completely close the trigger could result in incomplete clip closure and possibly compromise hemostasis.If trigger is only partially closed, a new clip may not load upon opening.In this case the trigger should be fully closed and opened to load the next clip.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: REFLEX ELC,20M/L CLPS,10/11MM
• Common Device Name: APPLIER, HEMOSTATIC CLIP
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15713532
• Report Number: 1320894-2022-00222
• Device Sequence Number: 14726524
• Product Code: HBT
• UDI-Device Identifier: 30653405074810
• UDI-Public: (01)30653405074810(17)251101(10)202011021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K924929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 11/01/2025
• Device Model Number: 530
• Device Catalogue Number: 530
• Device Lot Number: 202011021
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic