FDA Adverse Event
Malfunction
Summary report: N
ASM,HEAD,IMAGE1 S,H3-ZA, CE
MDR report key: 24968250
·
Received April 23, 2026
Report
- Report Number
- 2027009-2026-00905
- Event Type
- Malfunction
- Date Received
- April 23, 2026
- Date of Event
- April 7, 2026
- Report Date
- April 23, 2026
- Manufacturer
- KARL STORZ IMAGING
- Product Code
- FET
- UDI-DI
- 04048551333969
- PMA / PMN Number
- K131953
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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).
Description of Event or Problem · 0
IT WAS REPORTED THAT CAMERA HEAD IS DEFECTIVE OUT OF THE BOX AND FLICKERED DURING FIRST CASE USED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029070 | ASM,HEAD,IMAGE1 S,H3-ZA, CE | ASM,HEAD,IMAGE1 S,H3-ZA, CE | FET | KARL STORZ IMAGING | TH104 | 04048551333969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |