MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-12-19 for FORCEPS MCL19BIS RIGHT BOUCHAYER HEART manufactured by Integra Microfrance S.a.s..
[130990972]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[130990973]
It was reported that on (b)(6) 2018 during an laryngomicroscopy with twinstream and co2 laser operation, while trying to? Catch? The removing tissue, it was noticed under the microscope that half of the forceps were defective. The device, forceps mcl19b is right bouchayer heart had been used before and it was? Unbroken?. The forceps were placed in water and wiped clean with gauze. The instrument table, gauze and floor were examined to try and locate the missing part. The surgeon also checked the operating area and performed fiber bronchoscopy to check the patient? S lungs. The part was not found. There was minor harm reported and extra work that occurred during the operation. Request for additional information has been sent. Additional information was received on 17dec2018 stating that the patient was a (b)(6) woman, who had an increase time of 10? 15 minutes during her operation. An x-ray was performed the next day and no foreign object was detected. It is unknown if there was any underlying medical condition and if the patient had any symptoms/consequences due to the un-found broken part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00178 |
| MDR Report Key | 8181612 |
| Report Source | FOREIGN |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2012-10-15 |
| Date Added to Maude | 2018-12-19 |
| 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 | FORCEPS MCL19BIS RIGHT BOUCHAYER HEART |
| Generic Name | PFM11 |
| Product Code | KAE |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2019-01-02 |
| Catalog Number | MCL19BIS |
| Lot Number | 121002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-12-19 |