MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC INSULATION TUBE; RESECTOSCOPE SHEATH, INNER FIXED SHEATH

Model Number 27040XA

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

The ceramic tip fractured/broke from the sheath.The sheath has a date code of june 2016 and the pictures show stress fracture from possible old age/use.

Event Description

Allegedly, during a turb procedure, the ceramic tip of the sheath broke off inside the patient's bladder.The doctor was able retrieve the broken piece with graspers.No harm to the patient; and procedure was completed with no other surgical intervention required.

• Brand Name: INNER CERAMIC INSULATION TUBE
• Type of Device: RESECTOSCOPE SHEATH, INNER FIXED SHEATH
• 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: 10586320
• MDR Text Key: 209147269
• Report Number: 9610617-2020-00105
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: TT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• 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: 58 YR
• Patient Weight: 84