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 2018-01-11 for ZZ**C8702, M ALEXIS LAP SYS W/ KII FIO 101135901 manufactured by Applied Medical Resources.
[97776862]
No product is being returned for evaluation but lot number is provided. A device history report is to be reviewed by engineering. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[97776863]
Procedure performed: laparoscopic anterior bowel resection. The surgeon attempted to extract the alexis retractor from the patients abdomen. And the mid draping sheet teared off and slipped off inside the abdomen. Surgeon has complained that tearing of the sheath should not have happened patient status: n/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00013 |
| MDR Report Key | 7184706 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-11 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2018-01-11 |
| 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 | ZZ**C8702, M ALEXIS LAP SYS W/ KII FIO |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-01-11 |
| Model Number | C8702 |
| Catalog Number | 101135901 |
| Lot Number | 1298995 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-11 |