MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06,07 report with the FDA on 2015-02-12 for C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX 101256901 manufactured by Applied Medical.
[5440992]
Lap chole - "long procedure of 3. 5hours. Needed suction irrigation often. Each time the surgeon used the suction and then put it back in the scabbard the gurgling noise indicated that the suction was still on. And each time the scrub nurse needed to turn the dial back to turn off the trickle suction. The surgeon was frustrated by this as he wasn't intentionally turning it on. So when it kept coming on by accident it made it frustrating for the surgeon and the nurse. "
Patient Sequence No: 1, Text Type: D, B5
[12856315]
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 recently re-designed the handpiece which is 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 initial/ final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2015-00031 |
| MDR Report Key | 4513577 |
| Report Source | 01,04,05,06,07 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-02-12 |
| Date of Event | 2014-09-22 |
| Report Date | 2014-09-23 |
| Date Reported to Mfgr | 2014-09-23 |
| Date Mfgr Received | 2014-09-23 |
| Date Added to Maude | 2015-02-12 |
| 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 | 2015-02-12 |
| Model Number | C6001 |
| Catalog Number | 101256901 |
| Lot Number | 1228360 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-02-12 |