MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-07-17 for SUMMIT SWIVEL COLLIMATOR D800 manufactured by Summit Industries, Llc.
[4631348]
A summit swivel collimator, model # d800, fell from tube stand and contacted the leg of a pt. Pt was examined by a healthcare professional and released. No additional treatment necessary.
Patient Sequence No: 1, Text Type: D, B5
[12059674]
The collimator identified in this report was the subject of a recall (numbers z-1216/1218-2007) initiated on may 22, 2007 for this same problem. This collimator was sold to a distributor who went out of business prior to the recall. There were over 3000 collimators involved in the recall and today all that may be remaining in use are between 13 and 21 years old. Between july 2007 and january 2010 summit industries made a best faith effort to locate and repair as many of these collimators as possible. Due to the age of the collimator we were not able to locate all. Summit's final report was submitted to the fda on january 18, 2010 and the recall was reported "terminated" in a letter (received by summit industries) from the fda in march of 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450503-2014-00001 |
| MDR Report Key | 3972768 |
| Report Source | 08 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-06-05 |
| Date Mfgr Received | 2014-06-06 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2014-08-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM ENGEL |
| Manufacturer Street | 2901 WEST LAWRENCE AVE. |
| Manufacturer City | CHICAGO IL 60625 |
| Manufacturer Country | US |
| Manufacturer Postal | 60625 |
| Manufacturer Phone | 7733534030 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1216/1218-2007 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT SWIVEL COLLIMATOR |
| Generic Name | BEAM LIMITING DEVICE, IZX (892-1610) |
| Product Code | IZX |
| Date Received | 2014-07-17 |
| Model Number | D800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMIT INDUSTRIES, LLC |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-17 |