MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-06 for AFORCEPS MCL19 LEFT BOUCHAYER HEART manufactured by Integra Microfrance S.a.s..
[104542671]
The device was returned and evaluated. The reported issue was confirmed. A dhr review was performed and no anomalies related to the associated complaint were found. The device manufactured prior to november 2005 and no maintenance was performed by integra (b)(4) service and repair during that time. The age of the instrument and the lack of maintenance can reasonably conclude that this event was not attributable to integra? S product. As the instrument is over 22 years old, we can conclude the jaw weakened with years of use and lack of maintenance.
Patient Sequence No: 1, Text Type: N, H10
[104542672]
It was reported that during a laryngoscopy with biopsy, the jaw of the forceps broke and the broken part fell inside the mouth of the patient. The event led to an increase of surgery time of 1. 5? 2 hours. A fibro-optic bronchoscopy was used for aspiration of the broken part. The broken part was located in the right primary bronchus. Another device was available and used to complete the surgery. The patient was monitored in inpatient for two days under bronchial surveillance with aerosol and x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00050 |
| MDR Report Key | 7402344 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-06 |
| Date of Report | 2018-03-15 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-06 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE 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 | AFORCEPS MCL19 LEFT BOUCHAYER HEART |
| Generic Name | PFM11 |
| Product Code | MMO |
| Date Received | 2018-04-06 |
| Returned To Mfg | 2018-03-21 |
| Catalog Number | MCL19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-06 |