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 07/16/2019

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 12.The ceramic tip is broken in itself.However, slight discoloration due to fire damage is visible at the distal end.The ceramic tip has been machanically overloaded - damages like this happen if the ceramic insert is hit against hard objects ord edges.During intended use, there is no possibility to apply forces to achiev the defects.The warning notices with the correspondingifu indicate this.The burn marks indicate too high/ too long exposure to heat.The event is filed under internal karl storz complaint id (b)(6).

Event Description

It was reported that during the bipolar resection, the breakage of the terminal gray plastic component of the rotary sheat occured which required an endoscopic evacuation of all the plastic pieces of the sheat from the bladder of the patient.

• 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: 17031017
• MDR Text Key: 316280708
• Report Number: 9610617-2023-00653
• 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: ZS04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2017
• 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
• Patient Age: 75 YR