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

Model Number 27026EF

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

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 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.

Manufacturer Narrative

The correct product number is 2726ef.

• Brand Name: DEFLECTOR , CATHETER
• Type of Device: 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
• MDR Text Key: 194174185
• Report Number: 9610617-2019-00097
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551231876
• UDI-Public: 4048551231876
• Combination Product (y/n): N
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27026EF
• Device Catalogue Number: 27026EF
• Device Lot Number: WU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 109