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

Model Number	27040EB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.The event most likely was due to a large air bubble during resection.
Event or Problem Description
Allegedly, during a bladder resection to cauterize a bleeding urethra, an eruption occurred inside the patient's bladder which caused a perforation of the bladder.

• Brand Name: BIPOLAR RESECTOSCOPE
• Common Device Name: BIPOLAR WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 8972198
• Report Number: 9610617-2019-00079
• Device Sequence Number: 10844808
• Product Code: HIH
• UDI-Device Identifier: 04048551075623
• UDI-Public: 4048551075623
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27040EB
• Device Catalogue Number: 27040EB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/06/2019
• 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: Required Intervention
• Patient Age: 80 YR