MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-05-22 for SUMMIT SWIVEL COLLIMATOR D800 manufactured by Summit Industries, Inc..
[614266]
Summit swivel collimator model # d800 came free from the tubemount, landing on the table top, bumping the hand of a pt. The pt was receiving follow up care after wrist surgery. Subsequent x-rays indicated that the surgical work was unaffected by the incident and that no add'l injury resulted. The failure appears to have resulted from loose or missing hardware on the swivel assembly.
Patient Sequence No: 1, Text Type: D, B5
[7867483]
Summit industries has not yet received the subject unit for evaluation. The summit dealer was notified of the incident and went to the user facility (uf) where he determined that the collimator swivel retaining screws had become loose and/or were missing when the collimator fell. One or more of the remaining screws had possibly pulled out of the swivel mount assembly, stripping the last two of the 8 threads in the mounting assembly. To keep the clinic operating, he determined that replacing the original 1/4" retaining screws with 1/2" ones that fully engage the remaining 6 threads and adding lock-tight would be adequate until a replacement unit could arrive from the mfr, summit industries. At that time, the subject unit will be returned to summit industries for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450503-2007-00001 |
| MDR Report Key | 854510 |
| Report Source | 07 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-05-22 |
| Date of Event | 2007-05-15 |
| Date Facility Aware | 2007-05-15 |
| Report Date | 2007-05-22 |
| Date Mfgr Received | 2007-05-15 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 2007-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DON MATSON |
| Manufacturer Street | 2901 WEST LAWRENCE AVE. |
| Manufacturer City | CHICAGO IL 60625 |
| Manufacturer Country | US |
| Manufacturer Postal | 60625 |
| Manufacturer Phone | 7733534032 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT SWIVEL COLLIMATOR |
| Generic Name | BEAM LIMITING DEVICE |
| Product Code | KPW |
| Date Received | 2007-05-22 |
| Model Number | D800 |
| Lot Number | ND513-1298 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6.5 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 841352 |
| Manufacturer | SUMMIT INDUSTRIES, INC. |
| Manufacturer Address | CHICAGO IL 60625 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-22 |