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

Model Number 27040XA

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the factory for evaluation.

Event Description

As per a copy of a mir we received from the factory in (b)(4): tip has broken off from the tip.No problems with the patient but operation took approximately one hour longer to remove the tip out of the patient's body.A second operation was not needed.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.During the evaluation it was found that the inner shaft or the ceramic beak has broken off from the shaft.The inner socket was manufactured in 04/2017.The cause may be the use of aggressive cleaning agents during preparation or the amount of adhesive used during production.The rejected item has been inspected by construction.The construction has noticed that the shaft tube generally already looks very worn, and at the distal end where the beak is held by the shaft, this is no longer completely round.Thus, the glue was probably washed out also the shaft is from the year of manufacture 2017, which would also speak for the fact that the glue was washed out by the processing and thus the beak has loosened.The event is filed under internal karl storz complaint id (b)(4).

• 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, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11151493
• MDR Text Key: 227604931
• Report Number: 9610617-2021-00001
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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: RS10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• 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