MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for SONIC CLEANER manufactured by Steris Corporation - Distribution Center.
[64526060]
A steris service technician arrived on-site, inspected the unit, and identified that the s13 lid switch had failed causing the unit's motor to continue to run. As the motor continued to run, the wiring harness and chamber overflow hose became charred, causing the reported smoke. The sonic cleaner is being returned to steris for evaluation. Investigation of this event is currently in process. A follow-up mdr will be submitted when additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[64526061]
The user facility reported that smoke was emitting from their sonic cleaner. No injury, procedure delay, or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
[75655945]
Steris engineers evaluated the amsco sonic bath unit and identified damage to the components contained within the unit's cabinet structure, as well as the chamber door gasket and lid limit switch. During steris's evaluation of the amsco sonic bath, it was determined that water had seeped into the cabinet structure from the sonic chamber due to the damaged door gasket, which resulted in water contacting the internal electrical components contained in the cabinet structure. In addition to the compromised door gasket, damage to the seal of the device's lid limit switch was observed. This damage allowed water to contact the lid limit switch, creating a condition for the switch to overheat and damage the unit's internal electrical components. The overheating condition of the lid limit switch and additional internal electrical components resulted in the smoke reported by user facility personnel. The damage observed on the seal of the door gasket and lid limit switch was caused by improper use of the amsco sonic bath unit by user facility personnel. The damaged lid limit switch seal was caused by forceful manual operation of the unit's lid. The unit has been in use at the user facility since 2003; consistent manual operation of the lid can create stress on the lid limit switch seal and ultimately caused the damage observed during steris's evaluation of the unit. The damage to the door seal gasket is the result of improper loading and unloading of the device, specifically allowing the unit's instrument tray to contact the door gasket. The operator manual states, "chamber lid operates automatically. Attempts to manually open or close lid may cause damage. Do not place object on top of lid when unit is operating. " steris replaced the facility's amsco sonic bath with a steris ultrasonic cleaner as the amsco sonic bath is no longer manufactured by steris. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003950207-2017-00001 |
| MDR Report Key | 6229874 |
| Date Received | 2017-01-06 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-06 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Street | 6100 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONIC CLEANER |
| Generic Name | CLEANER |
| Product Code | FLG |
| Date Received | 2017-01-06 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Address | 6100 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |