MAUDE Adverse Event Report: CONMED CORPORATION SYSTEM 7550, 120V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 60-7550-120

Device Problem Gas Output Problem (1266)

Patient Problem Bowel Perforation (2668)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Reported event is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The service history could not be performed since a serial number was not provided.A review of the device history review could not be performed since a serial number was not provided.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4).Per the instructions for use, the user is advised the following: extended use of argon beam coagulation on the digestive tract (e.G., stomach, intestine and bowel) may lead to post-operative complications such as perforation and tissue rupture.Avoid applying energy to a localized area for durations in excess of one second.This issue will continue to be monitored through the complaint system to assure patient safety.

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created by the finding of maude report number (b)(4).The account and contact information for this report are not known.The (b)(4) was reported as, "during colonoscopy, provider directed probe of argon gas cautery to ablate a non-bleeding angiodysplastic lesion when it appeared to push a burst of argon gas into the submucosal tissue in a "ripple effect" resulting in a perforation of the colon." the event took place on (b)(6) 2021.The maude report does not indicate if the patient received treatment or prolonged hospitalization.The current status of the patient was not reported.This report is being raised on the basis of injury due to colon perforation.

• Brand Name: SYSTEM 7550, 120V
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 11921304
• MDR Text Key: 260234842
• Report Number: 1320894-2021-00276
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K050161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 60-7550-120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other