MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-01-06 for XOMED? INSTRUMENTS 3722058 manufactured by Xomed Microfrance Mfg.
[5369053]
It was reported? Malfunction of locking system: broken tip. It is the first time to use after purchasing.? Follow-up communications obtained additional information. The tip break resulted in a fragment. There was no patient impact or injury. Another instrument was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[12613183]
This device is used for therapeutic purposes. (b)(4). The device has been received and pending product analysis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34340653]
Product analysis was completed by the quality engineering team. As received condition: received 1 sample(s), part number 3722058. Equipment used: microscope (zeiss stemi 2000c between 0,65 to 5,0 magnification settings). Observations: when viewed under magnification, the tip was bent which would have resulted in the reported malfunction. Manufacturing and mishandling cannot be ruled out as potential causes. Based on the observations there are multiple potential causes and each is equally likely. There was no additional definitive evidence to indicate a root cause. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00003 |
| MDR Report Key | 4385305 |
| Report Source | 01,06,07 |
| Date Received | 2015-01-06 |
| Date of Report | 2014-12-14 |
| Date of Event | 2014-11-30 |
| Date Mfgr Received | 2015-01-15 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2015-01-22 |
| 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 | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT 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 | XOMED? INSTRUMENTS |
| Generic Name | PICK, MICROSURGICAL EAR |
| Product Code | JYT |
| Date Received | 2015-01-06 |
| Returned To Mfg | 2014-12-18 |
| Model Number | 3722058 |
| Catalog Number | 3722058 |
| Lot Number | 120704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-06 |