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

Model Number 27040XA

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Discomfort (2330)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned, therefore; no product evaluation has been done.

Event Description

Per the facility after a turp procedure, the tech noticed the ceramic tip of the sheath was chipped off.The doctor was informed, and x-rays taken in the operating room.The physician was not able to see any pieces of the beak left inside the patient and no other surgical intervention was 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: leigh spotten ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188738
• MDR Report Key: 11503991
• MDR Text Key: 240578713
• Report Number: 9610617-2021-00030
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• 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: XQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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