MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-29 for FORCEPS MCEN97 100MM 45DEG CVD LFT CUP manufactured by Medtronic Xomed Instrumentation S.a.s..
[17345051]
The device (part#mcen97) was returned to mxi service and repair.
Patient Sequence No: 1, Text Type: D, B5
[17552154]
The device (part#mcen97) was evaluated and indicated that one of the jaws was broken. Observation of the rupture area did not reveal any material, corrosion, or manufacturing defect. The break was probably sudden. From observation of the rupture area, the break very likely occurred suddenly after a shock or fall during use or reprocessing. (b)(4). 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 in 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00385 |
| MDR Report Key | 3337838 |
| Report Source | 01,07 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-02-05 |
| Date Mfgr Received | 2013-02-12 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-12-02 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 INSTRUMENTATION 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 | FORCEPS MCEN97 100MM 45DEG CVD LFT CUP |
| Product Code | KAE |
| Date Received | 2013-08-29 |
| Returned To Mfg | 2013-02-12 |
| Model Number | MCEN97 |
| Lot Number | 120603 |
| Device Availability | Y |
| 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 | 2013-08-29 |