MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for SCISSORS MCEN42 100MM CVD LFT ROUVIER manufactured by Integra Microfrance S.a.s..
[63319893]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[63319894]
It was reported that during a lateral right ethmoidectomy, the device blade broke in the sinus. The broken part was retrieved with no consequences on the patient however, physician think that there was a risk of injury when the broken blade was retrieved. The surgery was completed with another device and the event lead to surgical delay, unknown for how long.
Patient Sequence No: 1, Text Type: D, B5
[65920941]
Integra has completed their internal investigation on december 27, 2016. The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history. Results: evaluation of returned device; product or objective evidence was returned and the evaluation verified the complaint as valid. The fixed blades is broken at pin location. The aspect is different from manufacturing specifications. A thorough observation of the breakage area revealed oxidized material. Dhr review; no anomalies that could be associated with the complaint were observed. Complaints history; first occurrence for this risk for this device - no adverse trend. Conclusion: the instrument was not serviced by the manufacturer since its first use. However it has been modified by an external contractor no qualified by the manufacturer. This modification could have weakened the instrument and led to the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00207 |
| MDR Report Key | 6191713 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-02 |
| Date Mfgr Received | 2016-12-27 |
| Device Manufacturer Date | 2012-07-09 |
| Date Added to Maude | 2016-12-20 |
| 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 | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCISSORS MCEN42 100MM CVD LFT ROUVIER |
| Generic Name | PFM11 |
| Product Code | KBD |
| Date Received | 2016-12-20 |
| Returned To Mfg | 2016-12-08 |
| Catalog Number | MCEN42 |
| Lot Number | 201207MF2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-20 |