FDA Adverse Event
Malfunction
Summary report: N
OR1 NEO IP, ENH2 3.X
MDR report key: 23746886
·
Received December 8, 2025
Report
- Report Number
- 9610617-2025-02283
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Report Date
- December 8, 2025
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- LMD
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, A SERVICE TECH WILL BE SENT TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4). THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY.
Description of Event or Problem · 0
ACCORDING TO THE INFORMATION RECEIVED, ROUTING DISPLAY IS FREEZING UP. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2723998 | OR1 NEO IP, ENH2 3.X | OR1 NEO IP, ENH2 3.X | LMD | KARL STORZ SE & CO. KG | WUIS2548-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |