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

Model Number 27241BO

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was event with a "sheath".According to the information received, the ceramic tip is broken off.Further information is not available.

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 ceramic tip of the returned sheath was found to be broken.The broken off tip was also returned.The returned tip is showing an axial crack which starts at the top of the tip where also a small fragment is broken off.The crack was growing to the bottom where the tip was glued to the metal sheath.The crack was then stopped at the area of the gluing in axial direction and went on in circular direction which led to the breakage.Furthermore the ceramic tip shows a larger scratch on one side.No discoloration is visible on the breakage surface or the crack, which suspects a recent damage.The part of the ceramic which is glued to the metal is still fixed, the adhesion is intact.Due to the damages visible on the returned device the root cause most likely is a strong impact with an hard object wich caused the crack and subsequently the break.No indications for a material or a manufacturing issue where found during the investigation.

• 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: 17261974
• MDR Text Key: 318890613
• Report Number: 9610617-2023-00656
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943668
• 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: 06/29/2023

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: 27241BO
• Device Catalogue Number: 27241BO
• Device Lot Number: YS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• 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