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 Foreign Body In Patient (2687)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Ms.(b)(6) confirmed the broken piece from the instrument was left in the patient.The patient was contacted on 9/25/2019 by the surgeon for follow up and recommendations of another x-ray, and that she could not confirm the outcome and current status of the patient.

Event Description

Allegedly, during a hyperplasia benign prostatic hypertrophy procedure using green laser, a piece of the ceramic tip broke inside the patient's bladder, the doctor was unable to retrieve the piece.A kub x-ray confirmed the "metallic structure" within the mid/lower pelvis.The procedure was cancelled.

• 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: 9364771
• MDR Text Key: 194175216
• Report Number: 9610617-2019-00111
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/22/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2017
• 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: 58 YR
• Patient Weight: 68