MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-08-28 for RETRACTOR 130MM W/BLADE ROBIER [MXI/XOM] MCO357A manufactured by Medtronic Xomed Instrumentation S.a.s.
[3954344]
The device (retractor mco357a 130mm w/blade robier) was returned to mxi for service and repair. It was reported that the device is missing pieces and is stiff. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[11131985]
(b)(4). Analysis of the device (retractor mco357a 130mm w/blade robier) confirmed that the device is missing parts and is stiff. It was also determined that the instrument has physical damage. Note: this mdr is being filed as a result of an internal review of complaints from medtronic? S mxi facility in (b)(4). This review was conducted to resolve several issues discovered in the mxi complaint handling process. Issues resolved include the misclassification of devices returned for repair, as well as gaps in reporting. Mxi capa (b)(4) was opened to address these issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00423 |
| MDR Report Key | 3314281 |
| Report Source | 06,07 |
| Date Received | 2013-08-28 |
| Date of Report | 2011-05-02 |
| Date of Event | 2011-05-02 |
| Date Mfgr Received | 2011-05-02 |
| Date Added to Maude | 2013-11-27 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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 | RETRACTOR 130MM W/BLADE ROBIER [MXI/XOM] |
| Generic Name | RETRACTOR, ENT |
| Product Code | KAL |
| Date Received | 2013-08-28 |
| Returned To Mfg | 2011-05-02 |
| Model Number | MCO357A |
| Catalog Number | MCO357A |
| Lot Number | NONE PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-08-28 |