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 2017-07-12 for C8502, M ALEXIS LAP SYS 6/BX 101357101 manufactured by Applied Medical Resources.
[79967851]
Ra has received the event device and the product has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[79967852]
Procedure performed: lap donor nephrectomy event description: part of cap broke off and fell in patient. They use the cap to introduce cd004 without trocar. Addition information received on tuesday, july 4, 2017 that the hospital does not know for sure at what point the cap broke off, they noticed it because there was a leakage after tissue removal with inzii. They did not use any other instruments. With respect to experience the surgeon used the product around the 3rd or 4th time. Only the cap will be removed, they threw away the piece that broke off, so they only saved the cap. Comment from the hospital: ''we removed the kidney as usual through the port and placed the cap back on the alexis. We noticed that there was a leakage, very unpleasant. When we checked the cap for the leakage we noticed that a part of the cap was broken off. A piece of the seal. ''. Type of intervention: unknown. Patient status: no patient injury or illness occurred associated with the complaint event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-01900 |
| MDR Report Key | 6709305 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-12 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2017-07-12 |
| 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 | C8502, M ALEXIS LAP SYS 6/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-07-12 |
| Returned To Mfg | 2017-07-05 |
| Model Number | C8502 |
| Catalog Number | 101357101 |
| Lot Number | 1285187 |
| Device Expiration Date | 2019-12-14 |
| 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 | 2017-07-12 |