MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-02 for APPLIED SCIENCE ENDOCATCH BAG CD004 manufactured by Applied Medical.
[54880765]
During a laparoscopic nephrectomy applied science endocatch bag x2 did not open when fired. Md had to extend incision to manually remove kidney. No pt harm. Diagnosis or reason for use: kidney disease. Is the product compounded? No. Is the product over-the-counter? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064613 |
| MDR Report Key | 5938940 |
| Date Received | 2016-09-02 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-05-31 |
| Date Added to Maude | 2016-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APPLIED SCIENCE ENDOCATCH BAG |
| Generic Name | APPLIED SCIENCE ENDOCATCH BAG |
| Product Code | LIO |
| Date Received | 2016-09-02 |
| Model Number | CD004 |
| Lot Number | 1248683 |
| Device Expiration Date | 2018-06-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENDIA EMPRESA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-02 |