MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESTOSCOPE SHEATH; 27 FR. SHEATH

Model Number 27040AO

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

Patient Problem Insufficient Information (4580)

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation.The ceramic tip is broken off at the base of the resectoscope sheath.Part of the tip remains where it is adhered to the inside of sheath.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.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was an event with a 27040ao resectoscope sheath, 27fr.According to the information received, during a turp the tip of the storz resectoscope sheath broke off inside a patient.The surgeon removed the tip from the patient there was no report of patient harm.

Manufacturer Narrative

Manufacturing site evaluation.Ceramic insert broken off at the distal end.Based on the damage shown above, the breakage of the ceramic beak may have been caused by pulling the inner shaft out of the outer shaft at an angle.When the inner shaft is pulled out of the outer shaft at an angle this presses the ceramic against the outer shaft and can cause it to break.In addition, the ifu points out that the ceramic beak should be checked for damage before use.Most probable the root cause of the described failure is user-related.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: RESTOSCOPE SHEATH
• Type of Device: 27 FR. SHEATH
• 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, CA 90245 ; 4242188247
• MDR Report Key: 16553508
• MDR Text Key: 311584161
• Report Number: 9610617-2023-00061
• Device Sequence Number: 1
• Product Code: HIH
• 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,Followup
• Report Date: 09/11/2023

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: 27040AO
• Device Lot Number: PS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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 Sex: Male