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 2017-09-05 for C8501, S ALEXIS LAP SYS 6/BX 101357001 manufactured by Applied Medical Resources.
[85439452]
Applied medical has just received the event device and has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[85439453]
Procedure performed: lap hemi colectomy event description: "the sheath was torn during the surgery. " additional information was received via email from sales manager on tuesday (b)(6) 2017: the surgeon/staff realize the sheath was torn during the surgery, after being inserted to the patient body. There was no damage on the cap. Common laparoscopic instruments were used through the trocar on the cap. The sheath particulated and all material was retrieved. Type of intervention: unk. Patient status: "no patient injury".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-01970 |
| MDR Report Key | 6843986 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-05 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-09-05 |
| 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 | C8501, S ALEXIS LAP SYS 6/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-09-05 |
| Returned To Mfg | 2017-08-28 |
| Model Number | C8501 |
| Catalog Number | 101357001 |
| Lot Number | 1273550 |
| Device Expiration Date | 2019-07-05 |
| 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 | 2017-09-05 |