MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BALL END ELECTRODE, 3FR; 3FR ELECTRODE

Model Number	11770T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We evaluated the device and confirmed that the ball end of the electrode is missing, and the sheathing near the distal end is split open.Cause of this type of damage is not known.We have no similar complaints for this product/issue.
Event or Problem Description
Allegedly, during a cystoscopy procedure, a piece from the electrode broke off into the patient.The piece was retrieved and there was no harm to patient.

• Brand Name: BALL END ELECTRODE, 3FR
• Common Device Name: 3FR ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8283835
• Report Number: 9610617-2019-00016
• Device Sequence Number: 13874519
• Product Code: FAS
• UDI-Device Identifier: 04048551392584
• UDI-Public: 04048551392584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944795
• 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): 10/19/2018

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 Model Number: 11770T
• Device Catalogue Number: 11770T
• Device Lot Number: 37AH1673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 01/28/2019
• 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: 71 YR
• Patient Weight: 81