MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ASM,CAMERA HEAD,HX,1080P

Model Number	TH110
Medical Device Problem Codes	Optical Obstruction (3002); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference case id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the devices show an image distortion when used with a laser.The camera head saturates the whites and loses focus.No harm to patient, user or third reported.The procedure was completed successfully.Cross reference mdr: 9610617-2024-00472.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation product was returned on january 3,2025.The investigation is not completed yet.The investigation results are pending.Cross reference case id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: zc: 201030849 article: th110 lot: nm066491-k.The contacts of the plug on the camera cable were slightly dirty.However, this did not lead to the reported problems with image reproduction on the camera head.The optics window was slightly dirty; this was most likely caused by the wipe disinfection.Otherwise, no defects were found on the camera head.The camera head showed 68 switch-on cycles and 65 operating hours.Zc: 201030850 article: tc100 lot: xm892338-p no defects found during the inspection the camera control unit showed 77 switch-on cycles and 100 operating hours.Conclusion: the failures found on th110 are not causative for the described issue.The customer's failure description "tc100es and th110 show an image distortion when used with a laser" could not finally be confirmed since the device is not tested with laser energy.However, the error specified by the customer is already known by the manufacturer.This relates to the application with the visible light component when using a laser and the incompatibility in use with the c-mos sensor of the camera head (hx model series).The ifu contains a hint to this phenomenon.Additionally, customer information is available on demand, provided by product management via the technical service department.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,CAMERA HEAD,HX,1080P
• Common Device Name: ASM,CAMERA HEAD,HX,1080P
• 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: 20792599
• Report Number: 9610617-2024-00470
• Device Sequence Number: 7809043
• Product Code: FET
• UDI-Device Identifier: 04048551358924
• UDI-Public: 04048551358924
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K160044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: TH110
• Device Catalogue Number: TH110
• Device Lot Number: NM066491-K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 02/13/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown