MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DEFLECTOR , CATHETER; DEFLECTING MECHANISM WITH 2 INSTRUMENT CHANNELS

Model Number	27026EF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was evaluated and confirmed the distal deflector mechanism is broken off and there is corrosion around the area.The date code of the product is 2015.The instrument has been in use for 4 years.The tip was retrieved from inside the patient and the procedure completed with no harm to the patient.
Event or Problem Description
Allegedly per the customer, during a cystoscopy with biopsy the tip of the deflector mechanism broke off while inside the patient.The tip was retrieved in one piece with no harm to the patient.Once the piece was retrieved the procedure continued and completed.
Additional Manufacturer Narrative
The correct product number is 2726ef.

• Brand Name: DEFLECTOR , CATHETER
• Common Device Name: DEFLECTING MECHANISM WITH 2 INSTRUMENT CHANNELS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9176615
• Report Number: 9610617-2019-00097
• Device Sequence Number: 14107194
• Product Code: ODB
• UDI-Device Identifier: 04048551231876
• UDI-Public: 4048551231876
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K943697
• 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,Followup
• Report Date (Section B): 10/10/2019

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: 27026EF
• Device Catalogue Number: 27026EF
• Device Lot Number: WU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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: 76 YR
• Patient Weight: 109