MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2014-10-30 for MICROFRANCE? INSTRUMENT MCO5E manufactured by Medtronic Xomed Instrumentation S.a.s.
[5035904]
It was reported that the tip of the product broke off into the patient during the procedure. The instrument broke into two pieces. They were able to retrieve both pieces that fell into the patient. This caused a delay of surgery of 20 minutes. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12481219]
This device is used for therapeutic purposes. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[37070397]
On november 26, 2014, additional information was received: "procedure- endoscopic sinus surgery. The broken piece fell into the oralpharynx. We had to do a laryngoscopy to remove the piece through the mouth. " lot # 11-06. Device returned to mfr: 12/10/2014. The instrument was returned for evaluation. Product analysis found "the tube is broken right after the weld with the handle. It is also strongly bent. No material or welding or manufacturing defect was found. Considering the distortion of the tube and the age of the instrument (8 years), the most probable cause of this rupture is the successive important efforts [stress] during the life of the instrument. " device manufacture date: 11/2006. Method: actual device evaluated; visual inspection ; labeling evaluation. Results :stress problem; fatigue problem. Conclusion: use error caused or contributed to event.
Patient Sequence No: 1, Text Type: N, H10
[37070398]
On november 26, 2014, additional information was received: "procedure- endoscopic sinus surgery. The broken piece fell into the oralpharynx. We had to do a laryngoscopy to remove the piece through the mouth. "
Patient Sequence No: 1, Text Type: D, B5
[102626092]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00090 |
| MDR Report Key | 4214469 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2014-10-30 |
| Date of Report | 2014-10-06 |
| Date of Event | 2014-10-06 |
| Date Mfgr Received | 2014-11-26 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2014-11-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFRANCE? INSTRUMENT |
| Generic Name | KNIFE, EAR |
| Product Code | JYO |
| Date Received | 2014-10-30 |
| Returned To Mfg | 2014-12-10 |
| Model Number | MCO5E |
| Catalog Number | MCO5E |
| Lot Number | 11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INSTRUMENTATION S.A.S |
| Manufacturer Address | LE PAVILLON SAINT-AUBIN-LE-MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-30 |