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 2015-03-30 for C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX 101256901 manufactured by Applied Medical.
[5600988]
Unknown - "user reported the red button to be blocked in a suction position. As a consequence, suction was continuous. " patient status - "ok. "
Patient Sequence No: 1, Text Type: D, B5
[13039655]
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[25349022]
Investigation summary: the event unit was returned for evaluation. Upon inspection, engineering found that the handpiece was dismantled and was missing a spring. A spring was attached to the unit and the handpiece was actuated by repeatedly depressing the suction button. No defects were observed and the device functioned as intended. All final assembled handpieces are leak tested at both suction and irrigation valves to ensure the seal functions properly. Through user's interaction with the handpiece, the smoke evacuation feature may have been unintentionally activated. Applied medical continuously seeks to improve the form, function, and ease of use of its products. As part of this continuous process, applied medical has re-designed the handpiece intended to minimize the potential for this type of incident to occur. This lot was built prior to the implementation of these enhancements. This document represents our final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2015-00131 |
| MDR Report Key | 4642881 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-03-30 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-02-02 |
| Date Mfgr Received | 2015-03-03 |
| Date Added to Maude | 2015-03-30 |
| 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 | 2015-03-30 |
| Model Number | C6001 |
| Catalog Number | 101256901 |
| Lot Number | 1214618 |
| 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 | 2015-03-30 |