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 2017-11-21 for C8502, M ALEXIS LAP SYS 6/BX 101357101 manufactured by Applied Medical Resources.
[93445590]
The event unit was returned to applied medical for evaluation. Upon visual inspection, engineering confirmed the complainant's experience of a tear in the sheath. Based on the condition of the returned unit, it is likely that the reported event was caused by instruments that were used during the procedure. Engineering determined that the damage to the sheath was caused by outward stretching of the film from the puncture hole. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products. This report represents the initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[93445591]
Procedure performed -lap hemi colectomy. "this alexis was noticed that it was torn, when the scrub nurse unpack and check the product before use, during the surgery. " patient status- no patient injury or illness occurred that was associated with the complaint event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02121 |
| MDR Report Key | 7049795 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-21 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2017-11-21 |
| 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 | 2017-11-21 |
| Returned To Mfg | 2017-08-28 |
| Model Number | C8502 |
| Catalog Number | 101357101 |
| Lot Number | 1256507 |
| Device Expiration Date | 2018-10-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-11-21 |