MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; URETHROTOME

Model Number	27068L-S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While doing cystoscopy, round cold knife blade broke inside patient.Doctor retrieved it, xray taken.

• Brand Name: N.A.
• Common Device Name: URETHROTOME
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 13175523
• Report Number: 13175523
• Device Sequence Number: 11902554
• Product Code: EZO
• UDI-Device Identifier: 04048551394335
• UDI-Public: (01)04048551394335
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/22/2021
• Report Date (Section F): 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27068L-S
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 11/22/2021