MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG RESECTOSCOPE SHEATH INNER TUBE

Model Number	26040XA
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer confirmed to us that all pieces were retrieved and there was no patient impact.Also, per customer, the item is not available for evaluation.
Event or Problem Description
Allegedly, during a cystoscopy, laser lithotripsy bladder stone and change of suprapubic catheter procedure, the tip of the inner resectoscope sheath broke into pieces."the physician was able to retrieve missing pieces, except for a very minute piece of less than 2 mm, through the cystoscope".The bladder was thoroughly irrigated by the doctor.The patient was discharged on the day of the procedure.

• Brand Name: RESECTOSCOPE SHEATH INNER TUBE
• Common Device Name: RESECTOSCOPE SHEATH INNER TUBE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittlestrasse 8,; 78503; tuttlingen, ; GM
• MDR Report Key: 7170271
• Report Number: 9610617-2018-00001
• Device Sequence Number: 1448106
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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: Physician
• Device Model Number: 26040XA
• Device Catalogue Number: 26040XA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• 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: Other
• Patient Age: 78 YR
• Patient Weight: 107