MAUDE Adverse Event Report: KLS MARTIN GMBH + CO . KG CONMED BEAMER ESU CE200

Model Number BEAMER ESU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 02/10/2019

Event Type  Injury  

Manufacturer Narrative

The device was under examination in the distributor 's service center, where it was found that interface cable cb200- a03 did not make contact to unit ce200.A report is attached to this form.Whether the defective cable could be the cause for the adverse event could not yet be assessed.Till today, the device or the cable are not available for investigation at kls martin.

Event Description

Kls martin as the manufacturer of a device involved in an adverse event was informed that: during avm in the duodenum the electrosurgical device beamer esu ce200 and a conmed apc probe (a- beam- 4) were used.After surgery the patient was discharged.He returned to the er that afternoon and x - rays showed free air in the abdomen, which is an indicator for bowel perforation.Emergency surgery was performed - small bowel resection via egd.

Manufacturer Narrative

The unit passed the testing required for release, indicating that replacing the cable addressed the error and the device is acceptable for usage.The unit was returned to the customer with a replaced cable.Only the interface cable was available for evaluation.The unit was under evaluation in the distributors's service center.The file is closed for (b)(6).

• Brand Name: CONMED BEAMER ESU CE200
• Type of Device: CONMED BEAMER ESU CE200
• Manufacturer (Section D): KLS MARTIN GMBH + CO . KG; am flughafen 18; freiburg, 79108 ; GM 79108
• MDR Report Key: 8439468
• MDR Text Key: 139426436
• Report Number: 9681383-2019-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K081 678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

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 Model Number: BEAMER ESU
• Device Catalogue Number: CE 200
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONMED APC PROBE (A- BEAM- 4); CONMED APC PROBE (A- BEAM- 4)
• Patient Outcome(s): Hospitalization; Required Intervention