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 09/30/2019

Event Type  Injury  

Event Description

Breakdown of the distal part of the rotatory shirt movement and its detachment in the operating channel.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.Upon evaluation parts of the ceramic tip were found to be broken off.The broken off parts were not returned.A full thickness crack with chipping on the edge was discovered at the tip.There is a ring of discoloration visible which suspects thermal damage.Most likely an initial crack was induced by hitting the object against an other object.Cracks can grow over time, material stress due to heat change can accelerate the process.The device was manufactured in april 2016.The root cause most likely was a high force impact which led to a crack and finally to the break of the ceramic tip.Sheaths with ceramic tips must be handled carefully.The sheaths must be checked for cracks or other damages according to the ifu.No indication for a material or manufacturing related issue.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: 17031030
• MDR Text Key: 316298557
• Report Number: 9610617-2023-00654
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: RT10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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): Other