MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-02-02 for MICROFRANCE? INSTRUMENT MCL-S22 MCLS22 manufactured by Xomed Microfrance Mfg.
[5499270]
It was reported that? The jaw of the forceps was broken,? A back-up device was used to complete the procedure; there was no patient involvement. It has been clarified that the?? Sl? Part was fallen out from the device.?
Patient Sequence No: 1, Text Type: D, B5
[12799542]
(b)(4). This device is used for therapeutic purposes. Concomitant device: mcl-s21: forceps mcl-s21 right sataloff heart, lot 200901mf4 manufactured: january 2009. (b)(4): product evaluation: no analysis available; device not received for evaluation. Method: no testing methods performed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[34459093]
Model #: mcl-s22. Device available for evaluation? Yes returned to manufacturer: january 29, 2015. Date received by manufacturer: february 2, 2015 h3: product evaluation: analysis for mcl-s21, lot 090104mf3, found that the active part of the instrument is broken. The pin between the jaws did not resist. The tube is bent and there are impacts on the jaws. All the parts are still on the instrument. There is no risk of fragment in the patient. No material or manufacturing defect was found. The most probable cause of this breakage is an excessive effort during the use or the reprocessing of the instrument. Analysis for mcl-s22, lot 110903mf4, found that the clevis that holds the jaws is broken. The tube is bent. There are impacts on the jaws. However, there is no missing part; there is no risk of fragment in the patient. No material or manufacturing defect was found. The most probable cause of this breakage is an excessive effort during the use or the reprocessing of the instrument. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102626874]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00014 |
| MDR Report Key | 4475752 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-02-02 |
| Date of Report | 2015-01-08 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-02-02 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2015-03-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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 | MICROFRANCE? INSTRUMENT |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2015-02-02 |
| Returned To Mfg | 2015-01-29 |
| Model Number | MCL-S22 |
| Catalog Number | MCLS22 |
| Lot Number | 201109MF3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-02-02 |