MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELEMENT,WORKING.ONLY.SPRING; WORKING ELEMENT

Model Number	27050E
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer stated the electrode was a cook (b)(4) cutting loop and was used with a karl storz working element.The working element was evaluated by our field service technician, and confirmed by customer, that it most likely had been repaired by a 3rd party, to the material, shaft, collar and white block.
Event or Problem Description
Allegedly, during a transurethral removal of a prostate tumor, when the doctor seeded the loop into the white block to lock the electrode, it popped out.He tried a 2nd time and it popped out again, on the 3rd try when it popped out, it pulled and dislodged the urethra.An internal catheter was placed in the patient.

• Brand Name: ELEMENT,WORKING.ONLY.SPRING
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8592948
• Report Number: 9610617-2019-00044
• Device Sequence Number: 2075026
• Product Code: HIH
• UDI-Device Identifier: 04048551077542
• UDI-Public: 4048551077542
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27050E
• Device Lot Number: S LF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 05/08/2019
• 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 Age: 69 YR
• Patient Weight: 90