MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG HOPKINS; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	27292AMA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During percutaneous nephrolithotomy (pcnl), halfway through case, a screw came loose causing one of the levers to fall off.Both pieces fell on floor and were recovered.No harm to the patient.

• Brand Name: HOPKINS
• Common Device Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 13168097
• Report Number: 13168097
• Device Sequence Number: 4146021
• Product Code: FAJ
• UDI-Device Identifier: 04048551233771
• UDI-Public: (01)04048551233771
• 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): 11/16/2021
• Report Date (Section F): 11/16/2021

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
• Device Model Number: 27292AMA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 11/16/2021