MAUDE Adverse Event Report: CONMED UTICA 230CM POLYPECTOMY SNARE, OLYMPUS, SMALL OVAL; SNARE, FLEXIBLE

Model Number 100603

Device Problem Material Fragmentation (1261)

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

Event Date 05/19/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the device, 100603, 230cm polypectomy snare, olympus, small oval was being used on (b)(6) 2022."we had a small snare break and stick in a patient, when using cautery set at the usual 30, we had to retrieve the ¿stuck¿ piece from the patient¿s tissue." there was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed.Further assessment has been sent; however, to date no information has been obtained from the facility.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

Customer event ¿break and stick in a patient¿ was confirmed based on photographic evidence and device evaluation.A visual inspection was performed, the distal tip of the snare has evidence of melting.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.(b)(4).Per the instructions for use, the user is advised the following: do not pretest the snare with electrocautery outside of the patient.This could cause overheating of the snare and cause it to fray or break during the procedure resulting in a potential burn to the patient.Electrocautery unit settings are based on electrocautery unit performance, polyp size and physician preference.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Update: further assessment was received on 7jun22.There was no delay to the endoscopy procedure.Another snare was used to remove the fragment from the patient.The current status of the patient is not known.The sales representative reported on behalf of the customer that the device, 100603, 230cm polypectomy snare, olympus, small oval was being used on (b)(6) 2022 and "we had a small snare break and stick in a patient, when using cautery set at the usual 30.We had to retrieve the ¿stuck¿ piece from the patient¿s tissue." there was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed.Further assessment has been sent; however, to date no information has been obtained from the facility.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 230CM POLYPECTOMY SNARE, OLYMPUS, SMALL OVAL
• Type of Device: SNARE, FLEXIBLE
• 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: 14622730
• MDR Text Key: 296504701
• Report Number: 1320894-2022-00123
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 10653405053552
• UDI-Public: (01)10653405053552(17)231013(10)202110134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: 100603
• Device Catalogue Number: 100603
• Device Lot Number: 202110134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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
• Patient Ethnicity: Non Hispanic