MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC; ENDOSCOPE SHEATH, REUSABLE

Model Number 27050CA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

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 6.The event is filed under internal karl storz complaint id (b)(4).Upon the evaluation it could be confirmed that the ceramic beak is broken off.A yellow discoloration at the adhesive is visible, which is caused by several applications.The surface shows scratches and dents.In addition, the obverse surface in the flared, distal area is shiny, which indicates that the inner shaft is in contact with the ourter shaft.The root cause for the breakage of the ceramic beak is most likely, that the inner shaft was slightly canted, which exerted too much force on the ceramic tip.The damage of the product is not caused by a production problem or material defect.

Event Description

It was reported that there was event with a "inner sheath".According to the information received: during endoscopic resection of a bladder tumor, the small piece of bakelite attached to the end of the simple sheath of the storz bipolar resector broke and became detached inside the bladder.The doctor was forced to use a cystoscope and foreign body forceps in order to extract the piece of material.No clinical consequences.Further information is not available.

• Brand Name: INNER SHEATH FOR 27050 SC
• 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: 17261505
• MDR Text Key: 318475479
• Report Number: 9610617-2023-00645
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: PQ10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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