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

Model Number 27050CA

Device Problem Material Integrity Problem (2978)

Patient Problem Bruise/Contusion (1754)

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.Upon evaluation it could be confirmed that the ceramic tip is broken off.The sheath shows residuals of the adhesive were the ceramic is broken off.The tip shows a continuous crack and ceramic chipping near the edge of the tip.The break line starts at the edge of the tip and continues in circular way in the gluing area.The edge of the tip shows discoloration.The root cause most likely was mechanical damage to the ceramic tip which led to the crack and subsequent to the breakage.No indication for a material or manufacturing related issue was found during the investigation.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that a beak has broken off inside the bladder of the patient on one of the customer owned resectoscope sets.The surgeon was able to retrieve the beak entirely but the patient suffered some mild urethral trauma as a result.

• Brand Name: INNER SHEATH FOR 27050 SC
• Type of Device: INNER SHEATH FOR 27050 SC
• 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: 16974002
• MDR Text Key: 315792514
• Report Number: 9610617-2023-00644
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943668
• 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: 05/22/2023

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: NQ05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention