MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-29 for C6003, VALVE WITH DB TUBING 101471037 manufactured by Applied Medical Resources.
[61084662]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A follow-up report will be sent once the results have been analyzed. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[61084663]
Procedure performed unknown- translated: "suction became continuous without pressing the red button. Consequence for the patient: loss of pneumoperitoneum, risk of organ perforation by the instruments, bleeding not controlled. Consequence for the surgeon: loss time, no possibility to stop the bleeding because lack of visibility. Device contaminated with blood not kept. " patient status unknown.
Patient Sequence No: 1, Text Type: D, B5
[65837934]
The event product was not returned for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. A review of the manufacturing records for this lot confirmed that the product passed all manufacturing and quality inspections. Applied medical reached out to the user facility to verify the patient status and confirmed that the potential consequences of the event listed within the original complaint were hypothetical in nature and did not actually occur. Although the root cause of the event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. Additional information requested and received. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[65837935]
Additional information received (b)(6) 2016: consequences listed for this type of situation are hypothetical. Surgeon does not remember if the smoke evacuation button (red button) activated by rotating the red button clockwise at any point during the procedure. Suction pressures unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2016-00872 |
| MDR Report Key | 6133711 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-29 |
| Date of Report | 2017-01-24 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2016-11-29 |
| 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 | LOANANH NGUYEN |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C6003, VALVE WITH DB TUBING |
| Generic Name | FHF |
| Product Code | FHF |
| Date Received | 2016-11-29 |
| Model Number | C6003 |
| Catalog Number | 101471037 |
| Lot Number | 1258331 |
| Device Expiration Date | 2017-11-02 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-29 |