MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 300 D; ELECTROSURGICAL UNIT

Model Number VIO 300 D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bowel Perforation (2668)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

The involved esu was inspected/tested.The unit was found to be functioning as intended upon repairing damage to the generator that occurred during transportation.The evaluation included an electrical safety check, a functional check of each of the equipment's features and a power output check.The esu was/is within specifications and all features were/are functioning properly.In addition, no anomalies were found in the device history record (dhr) of the involved device.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.Anatomically, the removal of a flat lesion (polyp) can be challenging.A perforation is a rare but serious complication in the removal of lesions/polyps during a colonoscopy.A thermal injury (e.G., from hf-current) and/or mechanical injury (e.G., from the accessory) cannot be excluded as potential factors in the incident.However, no conclusive determination could be made as to the cause of the event.No trends have been identified and erbe usa, inc.Is now closing the file on this incident.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) upon a colonoscopy and an endoscopic mucosa resection (emr) to remove a flat polyp in the colon.The esu was used with a heynovo polypectomy snare (part number ws-2423d520, lot number 220727029).The setting of the esu was the endocut mode but the setting details were not provided.Additionally, it was reported that there were difficulties with the delivery of energy (i.E., cut and coagulation); even though the snare was correctly positioned with polyp.After removing the polyp, the resection site looked unremarkable.Nevertheless, a clip was placed at the site.Approximately 24 hours post-intervention, the patient went to the emergency room.During a second colonoscopy, a perforation was detected in the descending colon next to the emr site (i.E., where the flat lesion was removed).The perforation was about 15 mm in size.The hole was closed using a clip and then laparoscopically covered with an omental patch.The patient was then hospitalized for six (6) to seven (7) days.

• Brand Name: ERBE VIO 300 D
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-8764 ; 7709554400
• MDR Report Key: 17433982
• MDR Text Key: 320171839
• Report Number: 9610614-2023-00047
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K083452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 300 D
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 90 KG