MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-23 for RHOTON MICRO CURETTE ANG 1X2MM CUP 7-1/2 NL3785-014 manufactured by Carefusion.
[16725184]
During a cervical disk surgery, rhoton dissector (microcurette) broke off but the fragment was located by the neurosurgeon and removed. The original intended procedure was an anterior cervical disk fusion with allograft. The following is additional information obtained on (b)(4) 2011: the patient's original diagnosis was cervical discogenic disease c2-3 (l) and c 6-7 (l). The case was not delayed. The retrieval of the instrument part was straight forward and immediate and no additional anesthesia, surgical, or medical intervention was required. The piece fell into the incision but was removed easily using instrumentation at hand. The instrument was then set aside. Other instruments in the set were used in its place. The device was not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[17040729]
(b)(4). Carefusion medical device complaints were previously managed by cardinal health under a transitional service agreement from sept 1, 2009 to july 7, 2011. In retrospective review by carefusion representatives it was determined that this even necessitates submission as an mdr in adherence with 21 code of federal regulation part 803. No instrument was received for evaluation. The lot code cannot be determined without sample, and no lot code was reported. The current lot (at the time of the report) device history record was reviewed, with no issues found. Complaint trending analysis performed. No trend or issues were found for this type of complaint on this product code. Without the actual sample, the report cannot be confirmed nor could a root cause be assigned. No corrective actions taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2011-00008 |
| MDR Report Key | 2261031 |
| Report Source | 05 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-03-24 |
| Date of Event | 2011-02-21 |
| Date Mfgr Received | 2011-03-24 |
| Date Added to Maude | 2012-06-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHOTON MICRO CURETTE ANG 1X2MM CUP 7-1/2 |
| Generic Name | CURETTE, SURGICAL, GENERAL USE |
| Product Code | FZS |
| Date Received | 2011-09-23 |
| Model Number | NL3785-014 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-23 |