MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER ROTATABLE CERAMIC TUBE; 26FR. INNER TUBE ROTATABLE

Model Number 27050XA

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Laceration(s) (1946)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

The manufacturer's complaint reference number for this case is (b)(4).The surgeon was performing a turp and the ceramic tip of the inner sheath dislodged into the bladder.The surgeon was able to retrieve the ceramic tip.Patient had to have a urinary catheter placed after removal of the defective piece.The procedure was completed with another set up.

Manufacturer Narrative

Tthe evaluated product was found to have the broken ceramic beak, the rotating collar was gouged and multiple dents on shaft.The lot code was determined to be 11/2010 and is over 12 years old.Per the ifu warnings for sheaths with ceramic tips must be handled carefully and inspected prior to use for cracks.Damaged sheaths must never be used which could lead to a patient injury.In addition, only use obturators designated for sheaths with ceramic beaks.Incorrect obturators may cause damage to the beak.Additional per the ifu the reprocessing limits note the end of life is largely determined by wear and reprocessing methods.This unit is over the manufactures warranty.Possible over usage of the sheath (12yrs) is most likely the root cause for the breakage, with removal of the beak causing the injury.

• Brand Name: INNER ROTATABLE CERAMIC TUBE
• Type of Device: 26FR. INNER TUBE ROTATABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 15614894
• MDR Text Key: 304636398
• Report Number: 9610617-2022-00287
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 4048551078136
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: YZ02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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): Other
• Patient Sex: Male