MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 S H3-ZA AUTOCLAVE HIGH DEF CAMERA HEAD; ENDOSCOPIC CAMERA

Model Number	TH104
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the initial review upon receipt, the complaint was verified.The investigation is ongoing; a supplemental report will be submitted after the investigation has been completed.
Event or Problem Description
It was reported that there was an issue with the product th104 image1 s, h3-za camera head.Customer reported that the image went black during a laparoscopic salpingectomy procedure.Customer confirmed they were able to complete the case with another camera, and that there was no injury to the patient.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Investigation summary: complaint verified - a functional test confirmed that the customer's camera would not produce and image.During testing, a test fixture cable was installed, and the issue no the issue returned once again.The test fixture cable was swapped out with the customer's cable several times and the issue always followed the customer's cable.A cable characterization was unable to detect any issues, but when the customer's cable was used, troubleshooting found the cable (hot-head board) was unable to provide any of the proper voltages.This voltage issue did not occur when using a known working test fixture cable.Ultimately, the customer's cable will need to be replaced to address their issue.Root cause: a defective hot-head circuit board in the cable potting was not providing the proper voltages.

• Brand Name: IMAGE1 S H3-ZA AUTOCLAVE HIGH DEF CAMERA HEAD
• Common Device Name: ENDOSCOPIC CAMERA
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15814772
• Report Number: 2027009-2022-00307
• Device Sequence Number: 5661057
• Product Code: FET
• UDI-Device Identifier: 04048551333969
• UDI-Public: 4048551333969
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K131953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: TH104
• Device Catalogue Number: TH104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White