MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-26 for FORCEPS LEFT SATALOFF HEART [MXI/XOM] MCL-S22 manufactured by Medtronic Xomed Instrumentation S.a.s.
[22143079]
The device (forceps mcl-s22 left sataloff heart) was returned to mxi for service and repair. It was reported that the shaft is separated.
Patient Sequence No: 1, Text Type: D, B5
[22361370]
(b)(4): analysis of the device (forceps mcl-s22 left sataloff heart) confirmed that the device is out of spec. The tech adjusted, or replaced necessary components and tested the instruments to specs. 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 | 9680837-2013-00054 |
| MDR Report Key | 3307086 |
| Report Source | 05,06 |
| Date Received | 2013-08-26 |
| Date of Report | 2012-12-11 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2012-12-11 |
| Date Added to Maude | 2013-11-22 |
| 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 | SHARANYA JANGITI |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328183 |
| 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 | FORCEPS LEFT SATALOFF HEART [MXI/XOM] |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2013-08-26 |
| Returned To Mfg | 2013-02-15 |
| Model Number | MCL-S22 |
| Catalog Number | MCL-S22 |
| Lot Number | NOT 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 | 2013-08-26 |