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

Model Number 27050CA

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: 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 mechanically overloaded - most likely dropped what pre-damaged the ceramic tip.An indicator for this is the crack formation at the ceramic tip.Damages like this happen if the ceramic insert is hit against hard objects or edges.During intended use, there is no possibility to apply forces to achieve the defects.The warning notices with the corresponding pictures in the ifu indicate this.

Event Description

As per a vigilance report filed by our parent company in (b)(4), a part of the tip of an inner sheath, rotating, with ceramic insulation, came off during intervention and got lost in the uterus.The broken piece was removed from the patient.

• 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 90245-5017 ; 4242188201
• MDR Report Key: 9156869
• MDR Text Key: 194173778
• Report Number: 9610617-2019-00089
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2019

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: ZZ01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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