MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH WITH CERAMIC BEAK

Model Number 27050CA

Device Problem Material Separation (1562)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: upon evaluation it was confirmed that the ceramic tip is broken off.The sheath shows residuals of the adhesive where 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 ot the tip shows discoloration.The device was manufactured in january 2019.The root cause most likely was mechanical damage to the ceramic tip, which led to the crack and subsequently to the breakage.No indication for a material or manufacturing related issue was found during the investigation.

Event Description

As per a vigilance report filed with the (b)(6) by our parent company in (b)(6), the beak of the resectoscope sheath broke off inside the bladder of the patient.The surgeon was able to retrieve the beak entirely, but the patient suffered some mild urethral trauma as a result.

• Brand Name: INNER SHEATH WITH CERAMIC BEAK
• Type of Device: INNER SHEATH WITH CERAMIC BEAK
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9734564
• MDR Text Key: 195803024
• Report Number: 9610617-2020-00024
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention