FDA Adverse Event
Malfunction
Summary report: N
CONNECTING ARM
MDR report key: 24852634
·
Received April 11, 2026
Report
- Report Number
- 3002808148-2026-10874
- Event Type
- Malfunction
- Date Received
- April 11, 2026
- Report Date
- April 10, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- OCV
- PMA / PMN Number
- TO BE CONFIR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. IN ADDITION, THE INVESTIGATION FOUND THAT THE ARM COVER ADHESIVE PART WAS MISSING. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE ADDITIONAL REPORTED FAILURE(S) DID NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem · 0
IT WAS OBSERVED THAT DURING THE EVALUATION, THE CONNECTING ARM EXHIBITED THAT THE ARM COVER ADHESIVE PART WAS MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907757 | CONNECTING ARM | CONNECTING ARM | OCV | SHIRAKAWA OLYMPUS CO., LTD. | MH-498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |