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	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of the customer that the 530 reflex elc,20m/l clips were being used on (b)(6) 2023 during a laparoscopic cholecystectomy procedure and the clips "did not load straight properly from the beginning.¿ there was no impact or injury to patient/user.The procedure was completed with an alternate unknown device and there was no delay.Further information was received and it was found that the clips were scissoring."the clip came out crossed.The event was aware when the devise was used on a patient." no medical/surgical intervention or extended stay for the patient was reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 530 in unoriginal package.Lot number was able to be verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection, the complaint was not confirmed.The device functioned as intended.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 5 reports, regarding 7 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: endoscopic procedures should be performed only by physicians with adequate training and knowledge of these procedures.In addition, medical literature should be consulted regarding techniques, hazards, contraindications and complications prior to the performance of these procedures.Ensure the tissue or vessel fits completely within the confines of the clip or hemostasis may be compromised.When firing the instrument, squeeze trigger firmly as far as it will go.Failure to completely squeeze the trigger could possibly compromise hemostasis.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of the customer that the 530 reflex elc,20m/l clips were being used on (b)(6) 2023 during a laparoscopic cholecystectomy procedure and the clips "did not load straight properly from the beginning.¿ there was no impact or injury to patient/user.The procedure was completed with an alternate unknown device and there was no delay.Further information was received and it was found that the clips were scissoring."the clip came out crossed.The event was aware when the devise was used on a patient." no medical/surgical intervention or extended stay for the patient was reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 16972910
• Report Number: 1320894-2023-00090
• Device Sequence Number: 19468642
• Product Code: HBT
• UDI-Device Identifier: 30653405074810
• UDI-Public: (01)30653405074810(17)270313(10)202203141
• 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): 06/26/2023

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: 530
• Device Catalogue Number: 530
• Device Lot Number: 202203141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic