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 Date 07/25/2018

Event Type  Injury  

Event Description

It was reported that it came to a breakage of the inner sheath.The broken part was forced into the patient's bladder by the flushing and had to be recovered.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.The stem has been kinked - all the milled holes towards the flushing connection have been broken through.The ceramic beak is broken - the broken surfaces are not discolored.Various notches can be seen on the bayonet.The shaft was bent by force.The ceramic beak was also damaged.Based on the signs of use on the bayonet, it can be assumed that it was used frequently.The event is filed under internal karl storz complaint id (b)(4).

• 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: 17031024
• MDR Text Key: 316283194
• Report Number: 9610617-2023-00651
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: YS08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 05/31/2023
• 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
• Patient Outcome(s): Required Intervention