FDA Adverse Event
Malfunction
Summary report: N
OR1 FLEXRACK, PS16B, NEO IP
MDR report key: 24968288
·
Received April 23, 2026
Report
- Report Number
- 9610617-2026-00903
- Event Type
- Malfunction
- Date Received
- April 23, 2026
- Report Date
- April 23, 2026
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- LMD
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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, THE UPS SPARKED AND CAUGHT ON FIRE DURING CASE. LOST INTEGRATION VIDEO, MOBILE TOWER WAS ROLLED IN TO COMPLETE CASE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283499 | OR1 FLEXRACK, PS16B, NEO IP | OR1 FLEXRACK, PS16B, NEO IP | LMD | KARL STORZ SE & CO. KG | WUIS3818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |