MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-29 for CLEARGLIDE EVH SMALL KTV15 manufactured by Sorin Group Usa, Inc..
[1412579]
The clinician reported that during the procedure, the tip separated from the optical dissector. The piece was retrieved from the pt's leg. There was no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8512524]
A f/u report will be forwarded when pt info is available. The clinician reported that during the procedure, the tip separated from the optical dissector. The piece was retrieved from the pt's leg. There was no report of pt injury. Visual inspection of the returned optical dissector confirmed that the plastic tip had come loose from the metal shaft of the device. The handle of the device was also partially split open. The investigation is ongoing. A f/u report will be forwarded when the eval is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2009-00144 |
| MDR Report Key | 1577110 |
| Report Source | 05 |
| Date Received | 2009-12-29 |
| Date of Report | 2009-12-01 |
| Date of Event | 2009-11-30 |
| Date Mfgr Received | 2009-12-01 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2010-03-26 |
| 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 | CHERI VOORHEES, MGR. |
| Manufacturer Street | 14401 WEST 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676527 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARGLIDE EVH SMALL |
| Generic Name | OPTICAL DISSECTOR |
| Product Code | GCM |
| Date Received | 2009-12-29 |
| Returned To Mfg | 2009-12-09 |
| Model Number | NA |
| Catalog Number | KTV15 |
| Lot Number | 0925100116 |
| ID Number | NA |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA, INC. |
| Manufacturer Address | 14401 WEST 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-29 |