MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-21 for COLLIMATOR ACCESSORY LATCH EXL-8 * manufactured by Mitsubishi Intl Corp..
[19897867]
Collimator accessory latch failed during gantry movement causing the wedge mount tray and block mount tray to fall to the floor. A pt was on the treatment table and the trays barely missed the pt. A svc bulletin was issued by mfr regarding a problem of this nature. It calls for the parts to be inspected at the time of a pm as a minimum. A pm was done seven days prior to this incident. This bulletin was issued 12/28/89 and there has been no attempt that rptr is aware of to correct the defect. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010122 |
| MDR Report Key | 43973 |
| Date Received | 1996-10-21 |
| Date Added to Maude | 1996-10-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLIMATOR ACCESSORY LATCH |
| Generic Name | COLLIMATOR |
| Product Code | IYC |
| Date Received | 1996-10-21 |
| Model Number | EXL-8 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 44910 |
| Manufacturer | MITSUBISHI INTL CORP. |
| Manufacturer Address | TWO TOWER BRIDGE 1 FAYETTE ST STE 100 CONSHOHOCKEN PA 19428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-21 |