MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30 DEGREE; RIGID TELESCOPE

Model Number 26046BA

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: distal end has significant scratches as well as surface scratches along entire shaft.Dent in middle and proximal end of shaft.Also the scope has chipped rod lens.During evaluation of the scope while attached to a light source the item did not get warm.The event is filed under internal karl storz complaint id (b)(4).The ifu im-000003 ifu v17.0 (11-2019) warns "never place the end of a fiber optic cable or telescope connected to a light cable on or under a surgical drape while the light source is activated.The intensity of the light may cause burns to the patient and/or the surgical drape.".

Event Description

It was reported that there was an event with a r26046ba hopkins telescope 30°, 5 mm, 29 cm.According to the information received the surgeon was doing a laparoscopic procedure and the scope was still partly in the trocar/cannula, however the surgeon laid the scope on the patient's abdomen to get a better angle of view to the target area.Either the shaft of the scope or the light cable junction to the scope's light post then caused a patient burn.

Manufacturer Narrative

Manufacturing site evaluation: the optics were placed on the patient contrary to the warnings in point 2 of the ifu 97000026 which resulted in burns.The burns on the patient were caused by the user and not a production defect in optics.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE 30 DEGREE
• Type of Device: RIGID TELESCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16742497
• MDR Text Key: 313358665
• Report Number: 9610617-2023-00074
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551092132
• UDI-Public: 4048551092132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26046BA
• Device Catalogue Number: 26046BA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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): Other
• Patient Sex: Male
• Patient Weight: 122 KG