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 MCO13C ALLIG 3X0.6MM HARTMAN manufactured by Medtronic Xomed Instrumentation S.a.s..
[3730094]
Two devices (part# mco13c and scp337a) were returned for repair in mxi service and repair. "repair request under warranty: one broken alligator jaw microforceps ref. No. (b)(4) one rotating suction cannula ref: (b)(4) pierced".
Patient Sequence No: 1, Text Type: D, B5
[11178419]
Concomitant products: second device - scp337a (lot: 06/10) - mfg date: 06/2010. Complainant/facility: (b)(6). Eval of this instrument indicated that the end of the movable jaw was broken. Microscopic inspection indicated signs of excessive pressure and a clean break (no incipient fracture). The break was most likely a result of being dropped or excessive force on the jaw. Scp337a: eval of this device indicated that the tube was twisted and punctured. It is very likely that the tube suffered excessive torsion pressure (twisting), which lead to the puncture. Note: this mdr is being filed as a result of an internal review of complaints from medtronic's mxi facility in (b)(6). 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. Medtronic's internal reference #: na. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00219 |
| MDR Report Key | 3338009 |
| Report Source | 01,07 |
| Date Received | 2013-08-29 |
| Date of Report | 2012-05-30 |
| Date of Event | 2012-05-30 |
| Date Mfgr Received | 2012-05-30 |
| Device Manufacturer Date | 2011-09-01 |
| 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 | 3 |
| 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 MCO13C ALLIG 3X0.6MM HARTMAN |
| Product Code | KAE |
| Date Received | 2013-08-29 |
| Returned To Mfg | 2012-05-30 |
| Model Number | MCO13C |
| Lot Number | 201109MF4 |
| 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 |