MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR RESECTOSCOPE

Catalog Number	27050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Following dilatation of the penile urethra, a bipolar resectoscope was inserted via the urethra into the urinary bladder.Bladder lesion was resected in standard fashion while avoiding full-thickness bladder perforation or injury.Lesion was completely resected, and all chips were evacuated and sent to pathology for permanent section.Each area of lesion was resected separately.After resecting the left bladder neck and the prostatic urethra, the distal tip of the resectoscope broke off.The resectoscope was exchanged for a cystoscope; the broken tip was then able to be removed from the patient's urethra using an alligator grasper.No remaining fragments were seen in the bladder.

• Brand Name: BIPOLAR RESECTOSCOPE
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 10553223
• Report Number: 10553223
• Device Sequence Number: 2876904
• Product Code: FJL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/19/2020
• Report Date (Section F): 08/19/2020

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 Catalogue Number: 27050
• Device Lot Number: TQ06
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/19/2020