MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-04 for PRECISE LTM DIODE LASER 002-00176 manufactured by Cao Group, Inc..
[2638664]
Dental hygienist was performing a periodontal debridement procedure. During the procedure, a 6mm length of optical fiber broke off of the handpiece tip and was swallowed by the pt. Pt was not aware at the time that the fiber had been ingested. Pt has not reported any events or adverse health outcomes attributable to this event.
Patient Sequence No: 1, Text Type: D, B5
[9847477]
Device involved in incident is temporarily on loan to the health care provider while their usual unit is being repaired for an unrelated issue. Health care provider indicated that the procedure being performed when this event occurred was the first time that the hygienist has used this device for a periodontal debridement procedure. Health care provider has used this device on previous procedures. Manufacturer is unaware of the training status or supervision afforded to the hygienist surrounding this event. As of the date of this report, the health care provider's usual unit has been repaired and returned, and the manufacturer is awaiting return of the suspect device for eval. Manufacturer advised the health care provider to conduct periodic follow-up with the pt to determine if any additional problems arose related to this event. No reports of any additional issues from these follow-up activities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1725006-2012-00002 |
| MDR Report Key | 2577619 |
| Report Source | 05 |
| Date Received | 2012-05-04 |
| Date of Report | 2012-05-02 |
| Date of Event | 2012-04-16 |
| Date Mfgr Received | 2012-04-18 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-08-03 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROB LARSEN |
| Manufacturer Street | 4628 WEST SKYHAWK DRIVE |
| Manufacturer City | WEST JORDAN UT 84084 |
| Manufacturer Country | US |
| Manufacturer Postal | 84084 |
| Manufacturer Phone | 8014955503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NONE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE LTM DIODE LASER |
| Generic Name | LASER SURGICAL DEVICE |
| Product Code | LYB |
| Date Received | 2012-05-04 |
| Model Number | 002-00176 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAO GROUP, INC. |
| Manufacturer Address | 4628 WEST SKYHAWK DR WEST JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-04 |