MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-09 for SKYTRON 3501C EZ SLIDE * manufactured by Skytron.
[20738731]
The patient, scheduled for resection of recurrent colon cancer followed by intraoperative radiation, was placed on the skytron 3501c or table. The head board was attached to the footboard in accordance with manufacturer's guidelines to allow for maximum table extension for mobetron radiation unit use. The patient was prepped, given general anesthesia and positioning had begun. As the patient was placed into lithotomy position a loud crack was heard. The base of the skytron table snapped and the table broke across the main supporting central table stem. The patient slid toward the end of the table and onto the floor. The table tilt was at an angle that supported the patient's body alignment. The patient's airway and ett was secured while the patient was placed on a standard or table. The patient was examined and no harm noted post event. Surgical team staff surrounding the patient on the table suffered knee and foot surface contusions related to the table break. The mobetron was not compatable with the standard or table so intraoperative radiation therapy was completed utilizing an intrabeam machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2662667 |
| MDR Report Key | 2662667 |
| Date Received | 2012-07-09 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-06-12 |
| Report Date | 2012-07-09 |
| Date Reported to FDA | 2012-07-09 |
| Date Added to Maude | 2012-07-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON 3501C EZ SLIDE |
| Generic Name | OR TABLE |
| Product Code | BWN |
| Date Received | 2012-07-09 |
| Returned To Mfg | 2012-06-29 |
| Model Number | 3501C |
| Catalog Number | * |
| Lot Number | 4:155971 |
| ID Number | * |
| Device Availability | R |
| Device Age | 68 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON |
| Manufacturer Address | 5085 CORPORATE EXCHANGE BLVD S GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-09 |