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

Model Number 27040EB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

No device was returned for evaluation.The event most likely was due to a large air bubble during resection.

Event 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
• Type of Device: BIPOLAR 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 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 8972198
• MDR Text Key: 194170167
• Report Number: 9610617-2019-00079
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551075623
• UDI-Public: 4048551075623
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR