MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STARE RHINOSCOPE; HOPKINS OPTIC

Model Number 7230AA

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 04/14/2022

Event Type  Injury  

Event Description

Manufacturer incident report #(b)(4) received from the factory in germany: the surgeon reported his hand being burned by the light lead connected to a storz sinoscope.Details were vague but from what the customer could gather and after speaking to the doctor it seems normal practice that these leads get hot as they are a larger fiber bundle lead going into a smaller bore scope bundle.

Manufacturer Narrative

Since the product involved was not returned, a detailed investigation cannot be performed.The most probable root cause is that a too large light cable was used.When using a light cable that is too large, the amount of light is absorbed in the light adapter and converted into heat.Karl storz optics have a light cable coding that is also applied to the light cable to be used.This allows the correct combination between light cable and optics to be identified.Since a light cable from a third-party manufacturer was used in this case, this optical identification is not provided.

• Brand Name: STARE RHINOSCOPE
• Type of Device: HOPKINS OPTIC
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15417953
• MDR Text Key: 299861817
• Report Number: 9610617-2022-00268
• Device Sequence Number: 1
• Product Code: CCW
• 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
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7230AA
• Device Catalogue Number: 7230AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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