MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE ICC 200 EA; ELECTROSURGICAL UNIT

Model Number ICC 200 EA

Device Problem Output Problem (3005)

Patient Problem Bowel Perforation (2668)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

The esu was returned and thoroughly inspected/tested.A technical safety check was performed on the generator.This included an electrical safety check, a function check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications.In conclusion, no erbe equipment problem was found that would have caused or attributed to the event.Most likely, there were many factors involved in the reported event.However, the patient's condition of having a broad based polyp was a key factor in the outcome.Specifically upon the intervention work, the remaining tissue of the bowl did not stay intact as a result of the necrosis at the ablation site and then the delayed perforation.In conclusion, no determination could be made as to the cause of the event.No trends have been identified.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that the electrosurgical unit was involved in a patient incident upon a polypectomy.The esu was used to remove a broad based polyp.The generator was used with an erbe return electrode cable (part number 20194-058, lot number not applicable) and an erbe nessy omega return electrode (part number 20193-082, lot number 160810-0816).The return electrode was placed on the patient's right thigh.No information was provided regarding any other accessory used or the specific settings employed.During the polypectomy, there had been no abnormalities or detectable perforation.However days later, the patient came back with abdominal pain.Necrosis (including a delayed perforation) was found at the ablation site of the polyp.To address the issue, the patient underwent a partial resection of the transverse colon with additional hospitalization.

• Brand Name: ERBE ICC 200 EA
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; GM
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; GM
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-9317
• MDR Report Key: 8564402
• MDR Text Key: 143544050
• Report Number: 9610614-2019-00012
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K933157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICC 200 EA
• Device Catalogue Number: 10128-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Device Age: 20 YR
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100