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
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
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17232258
• Report Number: 9610617-2023-00141
• Device Sequence Number: 6969471
• Product Code: EOB
• UDI-Device Identifier: 04048551213698
• UDI-Public: 4048551213698
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K944797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male