MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER TUBE, FOR RESECTOSCOPE SHEATH

Model Number 26050XA

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

It could be confirmed that the ceramic tip of device was broken off.The device was manufactured in 2011.No indication for a material or manufacturing related issue was found during the investigation.Visible mechanical damaged is observed on the sheath.The root cause most likely was mechanical overload to the ceramic tip which led to breakage.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): tip broke off; the broken piece was left behind in patient's body.

• Brand Name: INNER TUBE, FOR RESECTOSCOPE SHEATH
• Type of Device: INNER TUBE
• 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: 10963000
• MDR Text Key: 229806979
• Report Number: 9610617-2020-00141
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551092668
• UDI-Public: 4048551092668
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26050XA
• Device Catalogue Number: 26050XA
• Device Lot Number: SY02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2011
• 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): Other