MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 26 FR.; ENDOSCOPE SHEATH, REUSABLE

Model Number 26040SL

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4).Upon evaluation no burning could be detected on the devices.Some usage marks could be detected on the sheaths.The outer sheath 26040sl was manufactured in january 2016.The inner sheath was manufactured in november 2018.No failure could be detected on the device.Therefore no root cause can be determined.Most likely an instrument used in combination was causing the described issue, which can not be confirmed.

Event Description

It was reported that there was event with a "working element".According to the information received: info from surgery - 26040sl very black, both items(26040sl and 26040xa) got very hot and burned.Patient injury is currently not known, because zsva has reported the incident.Further information is not available.

• Brand Name: RESECTOSCOPE SHEATH, 26 FR.
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17210130
• MDR Text Key: 318339514
• Report Number: 9610617-2023-00846
• Device Sequence Number: 1
• Product Code: HIH
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26040SL
• Device Catalogue Number: 26040SL
• Device Lot Number: NT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• 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
• Treatment: 26040XA INNER SHEATH, FIXED, FOR 26040SL