MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL

Model Number 27050XA

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.Bajonet on the sheath is broken.Metal sheath shows a drop of foreign glue at the edge towards the ceramics.The sheath shows a third party laser marking.The finish of the sheath is not according to karl storz specification (axial grinding scratches).Hence, it was most likely third party repair, where the ceramic tip got a pre-damage the event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that a ceramic beak on tip of resection sheath broke into several pieces whilst in use within the patients bladder.No further information available.

• Brand Name: INNER SHEATH FOR 27050 SL
• Type of Device: INNER SHEATH FOR 27050 SL
• 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: 17031016
• MDR Text Key: 317457387
• Report Number: 9610617-2023-00652
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

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: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: SU05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2015
• 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