ASM,HEAD,IMAGE1 S,H3-ZA, CE
Report
- Report Number
- 2027009-2025-01715
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Report Date
- February 23, 2026
- Manufacturer
- KARL STORZ IMAGING
- Product Code
- FET
- PMA / PMN Number
- K131953
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THE AFFECTED DEVICE WILL NOT BE RETURNED FOR INVESTIGATION TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THIS SUPPLEMENTAL CORRECTS THE H11 TEST OF THE PREVIOUSE SUBMISSION. THE COMPLAINT ISSUE WAS DESCRIBED AS WHEN PLUGGING INTO CAMERA NOT SHOWING IMAGE, SQUIGGLY LINES APPEAR. THE DEVICE WAS RETURNED TO KSUS AUBURN AND THE EVALUATION RESULTED AS NO PROBLEM FOUND. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THE DEVICE WAS RETURNED TO OUR US FACILITY, AND WAS PRELIMINARILY DEEMED TO BE NO PROBLEM FOUND. HOWEVER IT CAN NO LONGER BE FORWARDED TO THE MANUFACTURER FOR FURTHER EVALUATION DUE TO AN INTERNAL PROCESSING ERROR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
IT WAS REPORTED THAT "WHEN PLUGGING INTO CAMERA NOT SHOWING IMAGE. SQUIGGLY LINES APPEAR." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2005596 | ASM,HEAD,IMAGE1 S,H3-ZA, CE | ASM,HEAD,IMAGE1 S,H3-ZA, CE | FET | KARL STORZ IMAGING | TH104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |