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

Model Number 27050E

Device Problem Product Quality Problem (1506)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/21/2019

Event Type  malfunction  

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 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
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017
• MDR Report Key: 8592948
• MDR Text Key: 145791565
• Report Number: 9610617-2019-00044
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551077542
• UDI-Public: 4048551077542
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050E
• Device Lot Number: S LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 90