MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 26FR FIXED INNER TUBE W/CERAMIC INSULATION; RESECTOSCOPE SHEATH INNER TUBE

Model Number 27040XA

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

We have received no further details of the event, and no evaluation report has been received from the manufacturer as of yet.

Event Description

As per a copy of an initial mir filed with the (b)(6), which we received from the factory in (b)(6): ceramic tip on the instrument broke during use.

Manufacturer Narrative

As per the manufacturer evaluation report: upon investigation the instrument was found to have strong usage marks, dents and scratches.The engraving shows "w.Germany" the lot code gu points to a manufacturing date in july 1990.The broken off piece was not returned.The part of the ceramic tip which is glued to the steel shaft is still fixed, adhesion is intact.The remaining tip is showing some scratches/grinds and burning marks.The most likely root cause is a hit of the ceramic tip on a hard object which lead to an initial crack in the tip and subsequently to the breakage.The dents found on the sheath support the conclusion that there were several mechanical shocks/overloads.Cracks can grow over time, material stress due to heat change can accelerate the process.

• Brand Name: 26FR FIXED INNER TUBE W/CERAMIC INSULATION
• Type of Device: RESECTOSCOPE SHEATH INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10525519
• MDR Text Key: 207700212
• Report Number: 9610617-2020-00099
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: GU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention