MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for ADVANCED ANOXOMAT SYSTEM AN2CTS 2J-2G-220V manufactured by Andvanced Instruments.
[77523782]
The anoxomat instrument was returned. The broken anoxomat jar has not been returned. Root cause evaluation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[77523783]
Anoxomat jar fracture was reported. The jar fracture caused the jar lid to come loose and strike the operator in the face. The operator was treated for injuries and sent home.
Patient Sequence No: 1, Text Type: D, B5
[97135144]
The fractured jar and instrument were both returned for evaluation. The instrument was tested and found to perform per specifications. The inspection and evaluation of the jar exhibited excess crazing throughout the interior of the jar indicative of use of incorrect cleaning agents or repeated use/cleaning or a combination of the two. The jar was fractured and separated at the top clamping ring of jar. It was difficult to determine if there was any cracking at the fracture point prior to separation. However, the crazing in the jar indicates repeated use and possible decrease in structural integrity of the jar. Other jars at the facility were inspected and showed crazing and cracking around the top clamping ring from repeated use over a long use period. Company recommends inspection of jars after each use and removal from use when such crazing and cracks are visible. Root cause of the jar cracking could not be determined. Crazing and cracking from repeated use is suspected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217058-2017-00001 |
| MDR Report Key | 6637447 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-04-29 |
| Device Manufacturer Date | 2006-04-15 |
| Date Added to Maude | 2017-06-13 |
| 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 | MR EVAN MADDOCKS |
| Manufacturer Street | 2 TECHNOLOGY WAY |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7813209000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVANCED ANOXOMAT SYSTEM |
| Generic Name | ANOXOMAT |
| Product Code | KZJ |
| Date Received | 2017-06-13 |
| Model Number | AN2CTS |
| Catalog Number | 2J-2G-220V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANDVANCED INSTRUMENTS |
| Manufacturer Address | 2 TECHNOLOGY WAY NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-13 |