MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-08 for CUSA EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Lifesciences Ireland Limited.
[16008696]
Initially it was reported that the c2602 straight hand piece had reduced amplitude when in use. At the time it was not known if the device was in contact with the patient. If the patient was injured or death alleged or if the event led to an increase in the surgery time. On (b)(6) 2013, add'l info received changed the complaint to reportable. The info was as follows; the unit was not in contact with the patient. The unit had low amplitude. The patient was not injured however, the event caused the surgery to be delayed approx a half hour. The patient was anesthetized when the problem was found. The handpiece was changed and the surgery continued.
Patient Sequence No: 1, Text Type: D, B5
[16507882]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2013-00037 |
| MDR Report Key | 3113993 |
| Report Source | 05 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-04-22 |
| Date Mfgr Received | 2013-04-24 |
| Date Added to Maude | 2013-07-12 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099365560 |
| Manufacturer G1 | INTEGRA LIFESCIENCES IRELAND LIMITED |
| Manufacturer Street | IDA BUSINESS AND TECHNOLOGY PARK |
| Manufacturer City | SRAGH TULLAMORE 0000 |
| Manufacturer Postal Code | 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE |
| Generic Name | ULTRASONIC SURGICAL PRODUCTS |
| Product Code | LBK |
| Date Received | 2013-05-08 |
| Catalog Number | C2602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES IRELAND LIMITED |
| Manufacturer Address | IDA BUSINESS AND TECHNOLOGY PARK SRAGH TULLAMORE 0000 EI 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |