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 2013-08-20 for CLIP APPLICATOR MCEN21 110MM [MXI/XOM] manufactured by Xomed Microfrance Mfg.
[3710872]
A device (mcen21) was returned to service - repair alleging a "missing adjustment screw".
Patient Sequence No: 1, Text Type: D, B5
[11070344]
(b)(4). Results code is mechanical shock problem. Analysis found the mobile jaw was broken. The other jaw presents a significant trace of shock. The highlighted damages are probably the consequence of shocks during use or reprocessing. 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. Mxi internal reference #:(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00032 |
| MDR Report Key | 3299184 |
| Report Source | 01,06,07 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-04-08 |
| Date Mfgr Received | 2013-04-09 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2013-11-15 |
| 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 | 0 |
| 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 | CLIP APPLICATOR MCEN21 110MM [MXI/XOM] |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2013-08-20 |
| Returned To Mfg | 2013-05-07 |
| Model Number | MCEN21 |
| Catalog Number | MCEN21 |
| Lot Number | 200204MF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-08-20 |