MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. HOPKINS TELESCOPE 12°, 4 MM, 30 CM

Model Number 26105FA

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was rep[orted that the following was reported: "patient experienced tissue damage , burn on left side or vulva.Retrospective reporting due to only being made aware once the burn had healed and patient had been reviewed several weeks post operatively." up till now there is no information about the causative product given.The only information is that it was a resectoscope.Further information will be available as soon as the material arrives at manufacturing site or the customer provides the requested information.

Manufacturer Narrative

Additional information was provided in sections d1, d2, and d10 of this medwatch form.Corrected data in section g3 is included in this supplemental report.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Additional information was provided in section d4.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The claimed products were returned on (b)(6) 2024.The investigation of the products was completed on (b)(6) 2024.(b)(6) (inner sheath for resectoscope): there are traces of smoke / burn marks from the electrode on both sides (dark discoloration).Soiling/deposits can be seen at the distal end.During the inspection of the article, the above-mentioned damage was found.The device shows traces of smoke on the inside of the ceramic insert, which indicates that the inserted loop/electrode is burnt/sparkover.The presumably defective loop is not known and was not sent in for examination, so it cannot be examined in detail.The defects of the other returned devices are not related to thermal damages and therefore not relevant for the error analysis of the reported incident.Based on the above-mentioned investigation results, the defect of the inner sheath for resectoscope is a subsequent fault of a defective cutting loop/electrode.The defect is a result of a user fault.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 12°, 4 MM, 30 CM
• Type of Device: HOPKINS TELESCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA ; GM
• 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: 18305014
• MDR Text Key: 330231051
• Report Number: 9610617-2023-00393
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/18/2024
• 2 Devices were Involved in the Event: 1 2

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: 26105FA
• Device Catalogue Number: 26105FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 12/12/2023; 01/23/2024; 03/14/2024
• Supplement Dates FDA Received: 12/21/2023; 12/22/2023; 02/19/2024; 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 26050CA, BATCH NUMBER: TU01.; 26050CA.; 26050E, BATCH NUMBER: SU03.; 26050E.