MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-08 for 5085 SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[178579190]
A steris service technician arrived onsite following the reported event to inspect the 5085 surgical table and was unable to duplicate the reported event. No issues with the function or operation of the table were found, and the table was returned to service. After speaking with user facility personnel, the technician determined that the x-ray top accessory was not properly secured by user facility personnel prior to the procedure. The x-ray top is an accessory that attaches to the top of the table. As the surgical table was repositioned by user facility personnel, the x-ray top and patient began to shift off the table resulting in the reported "metal snap/pop" noise. The 5085 surgical table operator manual (pg. 5-28) states: "x-ray top installation: press down on x-ray top section until a "click" is heard. Ensure x-ray top sections are securely mounted by gently pulling up on section. " the 5085 surgical table operator manual (pg. 4-11) also states: "warning - personal injury hazard: when installing any table accessory, check for correct attachment and tighten securely (if appropriate). Check installation before using any accessory. " while onsite, the technician counseled user facility personnel on the proper use and operation of the surgical table specifically, properly installing the x-ray top accessory. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[178579191]
The user facility reported via medwatch # (b)(4) that during a patient procedure their 5085 surgical table was commanded to move towards the left via the table's hand control. As the table moved, the user facility personnel heard a "metal snap/pop. " the patient then began to shift off the table but was supported by user facility personnel. The patient was transferred to a different surgical table and the procedure was completed successfully. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2020-00003 |
| MDR Report Key | 9564845 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5085 SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | FQO |
| Date Received | 2020-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |