MAUDE Adverse Event Report: CONMED CORPORATION A-BEAM-3; ARGON PROBE

Catalog Number A-BEAM-3

Device Problem Use of Device Problem (1670)

Patient Problems Perforation (2001); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Complaint is inconclusive.Verbal complaint; device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A lot history review could not be conducted as a lot number was not provided.The device history record could not be reviewed as a lot number was not provided.A two-year review of complaint history revealed there has been 2 complaints regarding 2 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; never activate the argon beam probe when in direct contact to the tissue as this may cause a mild embolism or a risk of perforation.The distal end of the probe must always be within the field of view of the endoscope before and during activation of the beam.Never activate the beam without visually checking.Be sure that the proper path from the patient return electrode to the electrocautery unit is maintained throughout the procedure.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the a-beam-3, argon probe was used in the right colon during a avm ablation procedure.The doctor was using a higher setting (30w.7l/min) than recommended for a right colon ablation.The patient was re-admitted 24hrs later for a bowel perforation.The doctor does not think the machine or probe caused this injury.There was no delay in the procedure.This report is being raised based on patient injury due to the patient having to be re-admitted.

• Brand Name: A-BEAM-3
• Type of Device: ARGON PROBE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8457224
• MDR Text Key: 140034041
• Report Number: 1320894-2019-00061
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A-BEAM-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CE200, BEAMER MATE ESU, SN# (B)(4)
• Patient Outcome(s): Other
• Patient Age: 85 YR