MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR WORKING ELEMENT; BIPOLAR RESECTOSCOPE

Model Number 27040EB

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.

Event Description

We were served with a legal document, respondents in discovery, for a lawsuit against two facilities.The complaint indicated the patient underwent a cystoscopy with urethral dilation, transurethral resection/ablation of prostate with "button type bipolar prostate resector" and allegedly suffered thermal injury to his bladder and urethra.

• Brand Name: BIPOLAR WORKING ELEMENT
• Type of Device: BIPOLAR RESECTOSCOPE
• 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 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 8177027
• MDR Text Key: 130771187
• Report Number: 9610617-2018-00098
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551075623
• UDI-Public: 4048551075623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27040EB
• Device Catalogue Number: 27040EB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other