MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-25 for CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX 101388201 manufactured by Applied Medical Resources.
[184903143]
The event unit returned to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184903144]
Name of procedure being performed: "hepatectomy". Detailed description of event: hospital: (b)(4). "surgeon push the thumb ring forward to deploy the bag but the bag slipped out from metal prongs. " product is available for return. Additional information received via email on 04mar2020 from [name]: the tips of the prongs were exposed. The bag fell off the metal prongs immediately after the thumb ring was pushed forward. There were not multiple attempts to advance the actuator. Patient status: "fine. " type of intervention: ni.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00439 |
| MDR Report Key | 9878860 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-08-13 |
| 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 | CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-13 |
| Model Number | CD004 |
| Catalog Number | 101388201 |
| Lot Number | 1365531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |