MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR WORKING ELEMENT ONLY W/ SPRING

Model Number	27040EB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The working element proximal end saddle is dark, and possibly shorted.The shaft is bent and dented.These damages are not likely related to the patient injury.Injury to patient was most likely user error.
Event or Problem Description
Allegedly, during a trans-urethral resection of the prostate, forty minutes into the of surgery, the patient's obturator nerve was stimulated during the prostate resection; as a result, the prostate capsule was perforated and there was bleeding.The surgeon felt heat at the handle and could see smoke, therefore, he stopped the surgery.He changed instruments for a monopolar resectoscope to control the bleeding.The patient was hospitalized overnight.The patient will need a second surgery to complete the resection.

• Brand Name: BIPOLAR WORKING ELEMENT ONLY W/ 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: 8464984
• Report Number: 9610617-2019-00031
• Device Sequence Number: 13788459
• Product Code: HIH
• UDI-Device Identifier: 04048551075623
• UDI-Public: 4048551075623
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 27040EB
• Device Lot Number: XS07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/29/2019
• 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