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

Model Number 27040EB

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/28/2019

Event Type  malfunction  

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 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
• 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: 8464984
• MDR Text Key: 140342307
• Report Number: 9610617-2019-00031
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551075623
• UDI-Public: 4048551075623
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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