MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION SUCTION TUBE, 3.5 MM

Model Number	8606F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The complaint describes that the patients lip was burned with the item 8606f.It was reported that there was a cut in the shaft of the insulated hand piece.Spike from the exposed metal burned the patient's lip.In this complaint harm to the patient, surgeon or third party occurred.In conclusion, the complaint is considered as reportable.Device was not returned to manufacturer.
Event or Problem Description
It was reported that there was a cut in the shaft of the insulated hand piece.Spike from the exposed metal burned the patient's lip.

• Brand Name: COAGULATION SUCTION TUBE, 3.5 MM
• Common Device Name: COAGULATION SUCTION TUBE, 3.5 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17232655
• Report Number: 2020550-2023-00141
• Device Sequence Number: 7177428
• Product Code: EOB
• UDI-Device Identifier: 04048551213698
• UDI-Public: 4048551213698
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2023
• Report Date (Section F): 06/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8606F
• Device Catalogue Number: 8606F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male