MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-08-08 for 8066-910 manufactured by Western / Scott Fetzer Company.
[18916042]
During installation of portable equipment in a dental clinic, it was discovered by a medical gas verifier that the yoke index pins can be pushed out of the yoke body if the wrong gas cylinder is installed. This may compromise the pin index safety system of the yoke connection by permitting the connection of a gas cylinder post valve of one gas type to a yoke connection of another gas type. The problem was spotted before the unit was used for treatment. Western has not received any reports of such an improper connection nor any reports of a patient being exposed to an incorrectly-connected medical gas system. Thus, there have been no patient injuries associated with the affected product.
Patient Sequence No: 1, Text Type: D, B5
[19117195]
One nitrous oxide yoke assembly was returned. The right index pin was pushed inward approx. . 093 inches and was protruding from the back of the yoke body. The yoke pin holes extend through the back of the yoke body in these models. Testing of samples found the yoke pins can be pushed inward back through the yoke body with torques applied to the yoke screw in the range of 6-15 ft-lbs. This torque is 2 - 2 1/2 times greater than the torque that can be generated with the yoke screw supplied with the assembly. Investigation revealed various customer use practices that may contribute to the application of torques that may exceed those intended or typically needed to achieve a seal and which may exceed the force required to displace the pins. Mismatching gas types between post valve and yoke an/or misalignment between the two, use of different style yoke screws other than the style supplied and/or use of tools to tighten the yoke screw connection, use of different yoke seal washers other than the style supplied with the assembly, which may require increasingly higher torque to achieve a gas tight seal. Although the occurrence was considered remote, western is performing a recall of affected product. Western has designed a back-up plate to be installed between the medical gas yoke assembly and the manifold block to which it is attached. Once installed, the back-up plate serves as a positive stop for the yoke pins preventing them from being displaced and thereby maintaining the integrity of the yoke pin index safety system. Western has not received any reports of such an improper connection nor any reports of a patient being exposed to an incorrectly-connected medical gas system. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526809-2009-00001 |
| MDR Report Key | 1473070 |
| Report Source | 05,08 |
| Date Received | 2009-08-08 |
| Date of Report | 2009-08-07 |
| Date Mfgr Received | 2008-11-21 |
| Date Added to Maude | 2010-08-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID SIMO, DIRECTOR |
| Manufacturer Street | 875 BASSETT ROAD |
| Manufacturer City | WESTLAKE OH 44145 |
| Manufacturer Country | US |
| Manufacturer Postal | 44145 |
| Manufacturer Phone | 8007837890 |
| Manufacturer G1 | . |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | 1526809-8/7/09-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MEDICAL GAS YOKE ASSEMBLY |
| Product Code | CAM |
| Date Received | 2009-08-08 |
| Returned To Mfg | 2008-12-10 |
| Model Number | 8066-910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTERN / SCOTT FETZER COMPANY |
| Manufacturer Address | WESTLAKE OH 44145 US 44145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-08 |