MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-01-09 for MICROFRANCE? INSTRUMENT MCLS21R manufactured by Xomed Microfrance Mfg.
[16855918]
It was reported that the bottom part of tip of a right, heart-shaped grasper broke intraoperatively during a direct micro laryngoscopy suspension esophagoscopy on a (b)(6), female patient, weighing (b)(6) pounds. Search for the broken tip was unsuccessful, which included a x-ray of the neck, chest and abdomen postoperatively. There was no report of permanent patient impact or injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[17270933]
(b)(4). Method: no testing methods performed. (b)(4). This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[34318982]
In response to medtronic? S request for device return, the device was returned to the manufacturer for evaluation and repair (detailed as follows): the fixed jaw is broken and the fragment was not returned. The jaws? Thickness is compliant with the manufacturing specifications. A corroded area can be observed within the fracture zone, which suggests the presence of a crack prior to the breakage. The tube between the handle and the jaws is bent, however it has not been verified that this was part of the event and it might be due to transportation. Considering that no material or manufacturing defect was found and that there is evidence of a crack prior to the breakage, the most probable cause of this rupture is the recurrence of impacts on the instrument during its use, which weakened the jaw and progressively led to the reported event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102624169]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00009 |
| MDR Report Key | 4405326 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2015-01-12 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2015-01-12 |
| 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 | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| 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 | 2015-01-09 |
| Returned To Mfg | 2014-12-29 |
| Model Number | MCLS21R |
| Catalog Number | MCLS21R |
| Lot Number | 120901 |
| 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 | 1. Required No Informationntervention | 2015-01-09 |