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 2018-10-17 for G6313, L ALEXIS O C-SEC RET 5/BX 101356801 manufactured by Applied Medical Resources.
[124063073]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[124063074]
Name of procedure being performed: total abdominal hysterectomy. Dr performed a tah for large fibroid uterus and had been mobilising specimen before inserting alexis retractor during the procedure. Dr had packed away the bowel prior to inserting the inner ring but has made comment that she believes the inner ring caused bowel injury during the procedure. She found slight tearing of the sigmoid, transverse cut, later in the procedure but patient is doing well. Sales rep will be attending future tah cases where the surgeon wants to use the alexis with new sales rep to support surgeon and cover appropriate steps for insertion/removal. Patient status: slight tearing of the sigmoid, but patient is doing well type of intervention: unknown
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00390 |
| MDR Report Key | 7976180 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-17 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-17 |
| 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 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES |
| Manufacturer Street | 22872 AVENIDA EMPRESSA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G6313, L ALEXIS O C-SEC RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-10-17 |
| Model Number | G6313 |
| Catalog Number | 101356801 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2018-10-17 |