MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for CNGL3, GELPOINT MINI ADV ACCESS PLATFORM 101361901 manufactured by Applied Medical Resources.
[184903284]
The vent unit is anticipated to return for evaluation. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184903285]
Name of procedure being performed single incision laparoscopic cholecystectomy. Detailed description of event: product pouch is torn. The blister packaging was intact. Customer used the products in a procedure. From cer form: when opening the inner packaging it was recognized that the pouch was already torn. The parts of the device were taken out separately of the plastic blister and used. Additional information received from fitm by email on 06mar2020: the fitm discussed the case again with the or manager, who was quite sure that the pouch was torn at the moment they wanted to open it. They decided to have the product taken out of the blister by the sterile nurse. Additional information received from fitm by phone on 04mar2020: with "blister packaging", the tray inside the pouch is meant. The customer used the product because they did not realize that the tray is not a sterile barrier. Patient status: fine. Type of intervention: n/i.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00440 |
| MDR Report Key | 9879317 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-01-12 |
| Date Added to Maude | 2020-03-25 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNGL3, GELPOINT MINI ADV ACCESS PLATFORM |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-25 |
| Model Number | CNGL3 |
| Catalog Number | 101361901 |
| Lot Number | 1314929 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-25 |