MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-15 for RHOTON HOOK 90DEG BLUNT OVERLGTH 7-1/2IN NL3785-010 manufactured by Carefusion.
[3605124]
This complaint came to carefusion via a medwatch report number (b)(4): it was reported that the tip of the nerve hook instrument broke off and fell into the patient's heart during surgery. Attempts to find it with a magnet unsuccessful. X-ray of the patient did not reveal where the tip was at. X-ray done of cell saver and heart bypass filters. The tip was found in the cell saver filter. Comment 7/19/2013: this medwatch came with product number nl3185-010, carefusion rhoton hooks all present with a nl37 prefix. It is believed this was an error on part of the facility and the product is indeed our nl3785-010, this complaint reflects that? Product number. Writer will attempt to confirm with end user.? Additional information received 7/19/2013: it was reported that the device is available for evaluation.? Customer is requesting the device be returned after carefusion is done with the evaluation. The patient underwent an x-ray but no other medical intervention was preformed. The procedure was completed as planned. The facility confirmed that the tip was found in the filter of the cell saver. The facility has agreed to email photos of the device and x-rays.
Patient Sequence No: 1, Text Type: D, B5
[11055030]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24218414]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2013-00004 |
| MDR Report Key | 3290188 |
| Report Source | 05,06 |
| Date Received | 2013-08-15 |
| Date of Report | 2013-07-18 |
| Date of Event | 2013-05-31 |
| Date Mfgr Received | 2013-07-18 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2013-08-15 |
| 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 | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS 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 HOOK 90DEG BLUNT OVERLGTH 7-1/2IN |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2013-08-15 |
| Returned To Mfg | 2013-07-31 |
| Model Number | NL3785-010 |
| Catalog Number | NL3785-010 |
| Lot Number | D03 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-15 |