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 2016-05-26 for C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX 100668401 manufactured by Applied Medical.
[46070450]
Ra has received the incident device and the product has been assigned to engineering for evaluation. A follow-up report will be sent 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. There is no report of serious injury or death associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[46070451]
Laparoscopic appendectomy - "in surgery, this device was automatic suction and leak when client did not press the button. " patient status - "fine".
Patient Sequence No: 1, Text Type: D, B5
[62822282]
Investigation summary: the event unit was returned for evaluation. Upon inspection, engineering found no visible damages or defects; however the red knob was turned clockwise to the second level of smoke evacuation. A fluid leak test was performed by actuating the hand piece and running fluid through the tubing, hand piece and probe. No leakages were noted. The root cause of the incident remains unknown as engineering was unable to replicate the event; however, it is possible that the customer experience is due to use error. The instructions for use (ifu) states the blue irrigation button is used to irrigate, and the red suction button to aspirate. The user can activate smoke evacuation by rotating the red suction value clockwise until the desired aspiration level is achieved, and counterclockwise to deactivate smoke evacuation. Although the exact 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. In accordance with 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2016-00412 |
| MDR Report Key | 5683819 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-05-26 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-04-22 |
| Date Mfgr Received | 2016-04-28 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-05-26 |
| 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 | 9497138233 |
| 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 | 2016-05-26 |
| Returned To Mfg | 2016-05-06 |
| Model Number | C6001 |
| Catalog Number | 100668401 |
| Lot Number | 1245071 |
| Device Expiration Date | 2017-04-16 |
| Device Availability | R |
| 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 | 2016-05-26 |