MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH WITH CERAMIC BEAK; INNER RESECTOSCOPE SHEATH

Model Number 27050CA

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated.The ceramic tip was broken off.Damage is most likely due to the ceramic beak making contact with a hard surface, causing an internal crack and resulting in the breakage; we cannot confirm.

Event Description

Allegedly, during a turp procedure, the ceramic tip of the sheath broke off into the patient.They were unable to quickly retrieve the broken piece and, due to patient's excessive bleeding, they decided to wait until bleeding stopped to perform a subsequent procedure to retrieve the piece, which was performed four days later.There was no harm to patient.

• Brand Name: INNER SHEATH WITH CERAMIC BEAK
• Type of Device: INNER RESECTOSCOPE 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 90245-5017 ; 4242188201
• MDR Report Key: 8384584
• MDR Text Key: 139049999
• Report Number: 9610617-2019-00026
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2018

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: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: TS04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 03/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 85