MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 24 FR.; ENDOSCOPE SHEATH, REUSABLE

Model Number 27040BK

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4).The unit was investigated by the complaint department.According to the related investigation report, the soldering connection, the shaft and the clutch became loose.In addition, it could be confirmed that the device had signs of wear and tear.As most probable root cause it could be determined that the accelerated aging was caused by inproper reprocessing.

Event Description

It was reported that there was event with a "sheath".According to the information received, the tip of the resectoscope sheath has broken inside the bladder of a patient during the procedure.Further information is not available.

• Brand Name: RESECTOSCOPE SHEATH, 24 FR.
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17225769
• MDR Text Key: 318098295
• Report Number: 9610617-2023-00851
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040BK
• Device Catalogue Number: 27040BK
• Device Lot Number: KG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• 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
• Treatment: 27040BK RESECTOSCOPE SHEATH, 24 FR.
• Patient Outcome(s): Other