MAUDE Adverse Event Report: CONMED UTICA BEAMER ARGON PROBE 2.3MM 230CM (10/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	A-BEAM-3
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of their customer that the a-beam-3 beamer argon probe 2.3mm 230cm (10/cs) was being used on (b)(6) 2023 during an unknown procedure and ¿using argon probe in pt.Pulled the probe out of scope and little white tip was detached.No indication of harm to patient.Per physician performing the case the small tip <1mm will pass through the colon without issue¿.The procedure was completed without an alternate device and there was no delay.Patient has no issues from procedure.This report is being raised on the basis of injury due to fragment remaining in the patient.
Additional Manufacturer Narrative
The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.A 2 year lot history review found this is the only event for this lot number and failure mode.A device history record review was requested from the manufacturer and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of 1 report, regarding 1 device, 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 0.00002.Per the instructions for use, the user is advised the following: the distal end of the probe must always be within the field of view on the endoscope before and during activation of the beam.Never activate the beam without visually checking.The user is also precautioned to ensure the elevator is open before pulling the probe back or the tip could be damaged or could detach.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Update: per assessment received on 10mar23, lot number "212149 was left in the patient and the patient successfully passed the instrument with no issues".No medical/surgical intervention or pro-longed hospitalization was required for the patient.The patient was reported as "excellent health".The sales representative reported on behalf of their customer that the a-beam-3 beamer argon probe 2.3mm 230cm (10/cs) was being used on (b)(6) 2023 during an unknown procedure and ¿using argon probe in pt.Pulled the probe out of scope and little white tip was detached.No indication of harm to patient.Per physician performing the case the small tip <1mm will pass through the colon without issue¿.The procedure was completed without an alternate device and there was no delay.Patient has no issues from procedure.This report is being raised on the basis of injury due to fragment remaining in the patient.

• Brand Name: BEAMER ARGON PROBE 2.3MM 230CM (10/CS)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): KLS MARTIN GMBH & CO. KG; am flughafen 18; freiburg 79108 ; GM 79108
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16513095
• Report Number: 1320894-2023-00053
• Device Sequence Number: 6240095
• Product Code: GEI
• UDI-Device Identifier: 20653405056468
• UDI-Public: (01)20653405056468(17)240418(10)212149
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2024
• Device Model Number: A-BEAM-3
• Device Catalogue Number: A-BEAM-3
• Device Lot Number: 212149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic