MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-07-11 for C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX 101471030 manufactured by Applied Medical Resources.
[49234156]
The incident device is anticipated to return. A follow-up report will be provided upon completion of the 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
[49234157]
Hepatectomy - "in surgery after half hour, the red button was stuck so that cannot stop suction but the blood unable to draw. " type of intervention - unknown. Patient status - "fine".
Patient Sequence No: 1, Text Type: D, B5
[72902764]
Investigation summary: the event unit was returned for evaluation. Upon visual inspection, engineering observed that the aspiration knob of the returned unit was partially compressed and stuck in the open position. Engineering performed an actuation cycle test and confirmed that the aspiration knob was able to return to the closed position. The likely root cause of the stuck aspiration knob is aspirated material, such as viscous bodily fluid and tissue, becoming embedded in the aspiration port and seal. The aspirated material can increase the friction between the knob and the handpiece. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products. Additional information was requested and received.
Patient Sequence No: 1, Text Type: N, H10
[72902765]
Additional information received via email on july 29, 2016 from (b)(6) - "smoke evacuation feature was not activated. The handpiece or probe was checked after surgery, and opened device to confirm that it is normal. No kinking in the tubing. The pressure setting on the or wall suction was 300 mmhg. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2016-00512 |
| MDR Report Key | 5784391 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-07-11 |
| Date of Report | 2017-04-10 |
| Date of Event | 2016-04-21 |
| Date Mfgr Received | 2016-06-16 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2016-07-11 |
| 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 | JENNIFER SCOULLAR |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497133904 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX |
| Generic Name | FHF |
| Product Code | FHF |
| Date Received | 2016-07-11 |
| Returned To Mfg | 2016-09-13 |
| Model Number | C6001 |
| Catalog Number | 101471030 |
| Lot Number | 1258423 |
| Device Expiration Date | 2017-11-04 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-07-11 |