MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,INNER,CERAMIC INSULATION; UROLOGY INNER TUBE WITH CERAMIC BEAK

Model Number 27040XA

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

The broken instrument was returned for evaluation.We confirmed that the ceramic beak is broken off, the broken piece was not returned by the facility.The instrument had been in use for 2 years.Damage is most likely due to excessive force and/or handling of the device.

Event Description

Allegedly, during a cystolitholapaxy with laser procedure, a piece of the ceramic tip broke inside the patient, the doctor was able to successfully retrieve the piece.They removed the sheath and obtained another to complete the procedure with no further incident and no harm caused to the patient.

• Brand Name: TUBE,INNER,CERAMIC INSULATION
• Type of Device: UROLOGY INNER TUBE WITH CERAMIC BEAK
• 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 ; 4242188201
• MDR Report Key: 9290537
• MDR Text Key: 177253555
• Report Number: 9610617-2019-00102
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2019

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
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: NS06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68