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 2015-05-31 for C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX 101256901 manufactured by Applied Medical.
[5898955]
"surgeon believes the unit has too much suction. "
Patient Sequence No: 1, Text Type: D, B5
[13284965]
The incident device anticipated to return. A follow-up report will be provided upon completion of investigation. 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
[26089123]
Investigation summary: the event unit was returned for evaluation. Upon inspection, engineering tested the buttons for sticking, which could potentially cause continuous aspiration. The event unit was actuated and no defects were noted. The root cause could not be determined as engineering was unable to replicate the incident. All final assembled handpieces are leak tested at both suction and irrigation valves to ensure the seal functions properly. The vacuum pressure is controlled by the hospital suction source and not the product itself. No defects were noted with the product during the actuation test. This document represents our final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2015-00325 |
| MDR Report Key | 4807846 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-05-31 |
| Date of Report | 2015-08-16 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-05-08 |
| Date Added to Maude | 2015-05-31 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 949713-823 |
| Manufacturer G1 | APPLIED MEDICAL |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX |
| Generic Name | FHF |
| Product Code | FHF |
| Date Received | 2015-05-31 |
| Model Number | C6001 |
| Catalog Number | 101256901 |
| Lot Number | 1236736 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-31 |