MAUDE Adverse Event Report: KARL STORZ IMAGING ENDOSCOPE VIDEO CAMERA; IMAGE1 S HX-P

Model Number	TH111
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "mid surgery, when using the camera system alongside a diathermy, the stack lost the picture on the large monitor due to interference".Furthermore: "elongated and incomplete procedure.Possible requirement of secondary procedure.".
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The complained device was received at the manufacturing site on 2023-09-25 and were therefore available for investigation.The investigation has been completed on 2024-01-18.Findings: the camera head th111, serial number (b)(6) was tested with a set of test devices consisting of image is modular; tc200 (connect) and tc301 (x-link module) in continuous operation.The image reproduction was checked in the application with a 4mm endoscope and was qualitatively flawless.As soon as the rf test device (autocon ii 400) was activated with the hand-held unit, image interference occurred.During test operation with the autocon test device, however, no picture failure could be registered as reported by the customer.The exact same constellation as in the customer's application cannot be used in test operation as it is not known.It is likely that a defective / torn shielding on the camera cable in combination with the rf application caused this image failure.If the shielding on the camera cable is torn, the rf energy is inductively transferred to the signal cables on the camera head when activated and can interfere with or even interrupt the data transmission.This can lead to image failure.The interruption of the shielding on the camera cable is due to the movements in the application over time and is therefore considered as wear and tear.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to wear and tear.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Udi related data quality updates only: the initial mdr had the correct udi number but the first digit "0" was omitted.Please see section d4 of this mdr form for the updated udi number.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPE VIDEO CAMERA
• Common Device Name: IMAGE1 S HX-P
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• 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: 17886677
• Report Number: 2027009-2023-00279
• Device Sequence Number: 20558147
• Product Code: FET
• UDI-Device Identifier: 04048551358931
• UDI-Public: 04048551358931
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TH111
• Device Catalogue Number: TH111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 09/18/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 01/22/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown