MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-12-10 for C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX 101256901 manufactured by Applied Medical.
[5245048]
Unknown- "during use of the device suction was permanent even when the red button was not pressed consequence complete loss of pneumoperitoneum. "patient status - "ok. "
Patient Sequence No: 1, Text Type: D, B5
[12618629]
Investigation summary: the incident product was not returned for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the incident. A review of the manufacturing records for this lot reveals the lot passed all manufacturing and quality inspections. 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 in order to eliminate 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
[12639128]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A final 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
| Report Number | 2027111-2014-00379 |
| MDR Report Key | 4317895 |
| Report Source | 05,06,07 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-11-26 |
| Report Date | 2014-11-26 |
| Date Reported to Mfgr | 2014-11-26 |
| Date Mfgr Received | 2014-11-27 |
| Date Added to Maude | 2014-12-10 |
| 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 | 0 |
| 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 | 2014-12-10 |
| Model Number | C6001 |
| Catalog Number | 101256901 |
| Lot Number | 1213447 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-12-10 |