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

Model Number 11770T

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

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 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
• Type of Device: 3FR ELECTRODE
• 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 90245-5017 ; 4242188201
• MDR Report Key: 8283835
• MDR Text Key: 134339239
• Report Number: 9610617-2019-00016
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551392584
• UDI-Public: 04048551392584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944795
• 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: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11770T
• Device Catalogue Number: 11770T
• Device Lot Number: 37AH1673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 81