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

Model Number	530
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 530, reflex elc,20m/l clps,10/11mm was being used on (b)(6)2022 and ¿the clips do not close during the surgery¿.There was no impact or injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received two 530 in original unopened package.Lot number was verified.Performed a visual inspection on a sample size of two devices, no abnormalities or defects were confirmed within the device.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 (b)(4) reports, regarding (b)(4) 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: always check to see that a clip is in the jaws before squeezing trigger.Closing of empty jaws on tissue may cause tissue damage.Always ensure trigger is squeezed completely and allowed to open to full initial position.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Update: per assessment the procedure was a laparoscopic cholecystectomy.The procedure was completed with a 5 minute delay.The clips did not fall into the surgical site.The patient is "ok".There was no medical/surgical intervention or extended stay at the hospital required for the patient.The sales representative reported on behalf of the customer that the device, 530, reflex elc,20m/l clps,10/11mm was being used on (b)(6) 2022 and ¿the clips do not close during the surgery¿.There was no impact or injury to the patient.This report is being raised on the basis of 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: 16050325
• Report Number: 1320894-2022-00245
• Device Sequence Number: 6257908
• Product Code: HBT
• UDI-Device Identifier: 30653405074810
• UDI-Public: (01)30653405074810(17)270116(10)202201171
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K924929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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 Model Number: 530
• Device Catalogue Number: 530
• Device Lot Number: 202201171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic