| Brand Name | SINGLE USE ADAPTOR BIOPSY VALVE |
|---|
| Common Device Name | SINGLE USE ADAPTER BIOPSY VALVE |
|---|
| Manufacturer (Section D) |
| AOMORI OLYMPUS CO., LTD. |
| 2-248-1 okkonoki |
| kuroishi-shi, aomori 036-0 357 |
| JA 036-0357 |
|
|---|
| MDR Report Key | 20929441 |
|---|
| Report Number | 2429304-2024-01039 |
|---|
| Device Sequence Number | 20116115 |
|---|
| Product Code |
PSV
|
| UDI-Device Identifier | 04953170181009 |
|---|
| UDI-Public | 04953170181009 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter State | GA |
|---|
| Initial Reporter Country | US |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Serviced by Third Party (Y/N) | Unknown |
|---|
| Reporter Type |
Importer
|
|---|
| Initial Reporter Occupation |
Non-Healthcare Professional
|
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
12/13/2024 |
|---|
| Report Date (Section F) |
12/13/2024 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Operator of Device |
Health Professional
|
|---|
| Device Model Number | MAJ-1414 |
|---|
| Device Lot Number | KR271611 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Distributor Facility Aware Date | 11/15/2024 |
|---|
| Event Location |
Hospital
|
|---|
| Date Report to Manufacturer | 11/15/2024 |
|---|
| Initial Date Received by Manufacturer | Not provided |
|---|
| Initial Report FDA Received Date | 12/13/2024 |
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
Yes
|
|---|
| Usage of Device |
A
|
|---|
| Patient Sequence Number | 1 |
|---|
| Outcome Attributed to Adverse Event |
Required Intervention;
|
| Patient Sex | Unknown |
|---|
| Date Report Sent to FDA | 12/13/2024 |
|---|
|
|
