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

Model Number ICC 200 E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2024

Event Type  Injury  

Event Description

It was reported that the electrosurgical unit (esu/generator) was involved in a patient incident.The esu was used in endoscopic retrograde cholangiopancreatography (ercp).The generator was used with a sphincterotome and a grounding pad.When the physician stepped on the yellow pedal of the unit's footswitch, there was a more substantial cut than expected (note: per the doctor, the endocut light on the unit was not illuminated.Therefore, the settings were auto cut, effect 3, 200 watts).Then, clips were applied to the area due to a possible perforation and the patient was admitted to the hospital.On (b)(6) 2024, the patient was released from the medical facility.Note: the hospital's biomed checked the esu's outputs and found them within specification.

Manufacturer Narrative

The involved esu was returned and inspected/tested.The unit was found to be functioning as intended.The evaluation included an electrical safety check, a functional check of each of the equipment's features, and a power output check.The generator 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 device.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.Based upon the reported information, it appears that the desired mode (endocut) was not employed during the procedure.However, no conclusive determination could be made as to the exact cause(s) of the event.To further address the issue, additional in-service work was performed on 02/19/24 at the hospital with the involved medical personnel.Finally, the medical personnel are being made aware of the findings.No trends have been identified.Erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE ICC 200 E
• 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: 18874409
• MDR Text Key: 337316860
• Report Number: 9610614-2024-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

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: ICC 200 E
• Device Catalogue Number: 10128-204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2004
• 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
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White