MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2007-10-31 for CO2 YOKE 2026.64 manufactured by Richard Wolf Medical Instruments.
[743122]
It was reported that after completion of a transanal endoscopic microsurgery procedure, it was noted that a black nitrogen tank had been connected to the insufflator when a gray carbon dioxide cylinder should have been used. When the e-cylinder connecting yoke was examined, it was noted that it could be attached to the cylinder valve without the safety index pins coming in contact with the gas cylinder valve body. Further examination revealed that the yoke had been assembled with a dual threaded fitting that was too long for the yoke body. This resulted in the plastic sealing washer making contact with the cylinder prior to safety pin insertion. This defect would have allowed connection to any gas cylinder with any safety pin key configuration.
Patient Sequence No: 1, Text Type: D, B5
[8121278]
Evaluation summary - carbon dioxide cylinder yoke. On october 2, 2007 we were informed via fda medwatch report of the product problem. User facility returned the above device for evaluation. Visual inspection of the co2 yoke confirmed that the height of the nozzle was above the height of the index pins. This yoke was manufactured january 2001. Cause of event: device is out of specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2007-00036 |
| MDR Report Key | 936165 |
| Report Source | 00,06 |
| Date Received | 2007-10-31 |
| Date of Report | 2007-10-31 |
| Date of Event | 2007-09-10 |
| Date Mfgr Received | 2007-10-02 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2007-12-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO2 YOKE |
| Generic Name | CO2 YOKE |
| Product Code | CAM |
| Date Received | 2007-10-31 |
| Returned To Mfg | 2007-10-03 |
| Model Number | 2026.64 |
| Catalog Number | 2026.64 |
| Lot Number | 178R01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 935093 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-31 |