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

Model Number 27050XA

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to the manufacturer.No further details of the event are available.

Event Description

Per a copy of a report received from the factory in (b)(4), which was filed with the (b)(6): breakdown of the distal part of the rotatory sheath movement and its detachment in the operating channel.

Manufacturer Narrative

Upon evaluation parts of the ceramic tip were found to be broken off.The broken off parts were not returned.A full thickness crack with chipping on the edge was discovered at the tip.There is a ring of discoloration visible which suspects thermal damage.Most likely the an initial crack was induced by hitting the object against an other object.Cracks can grow over time, material stress due to heat change can accelerate the process.The root cause most likely was a high force impact wich led to a crack and finally to the breakage of the ceramic tip.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

• Brand Name: RESECTOSCOPE INNER TUBE
• Type of Device: INNER SHEATH
• 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: 10283203
• MDR Text Key: 199722843
• Report Number: 9610617-2020-00078
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 4048551078136
• 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,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050XA
• Device Catalogue Number: 27050XA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other