MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-08-30 for C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX 101473672 manufactured by Applied Medical Resources.
[158825891]
The event unit returned for evaluation. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[158825892]
Name of procedure being performed: robotic sigmoidectom. Detailed description of event: rep was present for the case. When surgeon was pulling the alexis out at the end of the procedure noticed there was a tear in the sheath by the green insertion ring. Sheath did not particulate. Device is available for return. Patient status: fine. Type of intervention: at the end of the case when the tear was noticed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00574 |
| MDR Report Key | 8952706 |
| Report Source | OTHER |
| Date Received | 2019-08-30 |
| Date of Report | 2019-10-22 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2019-08-02 |
| Device Manufacturer Date | 2019-03-01 |
| Date Added to Maude | 2019-08-30 |
| 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 | C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX |
| Generic Name | PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER |
| Product Code | KWG |
| Date Received | 2019-08-30 |
| Returned To Mfg | 2019-08-29 |
| Model Number | C8701 |
| Catalog Number | 101473672 |
| Lot Number | 1350774 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-08-30 |