MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-05 for C8501, S ALEXIS LAP SYS 6/BX 101357001 manufactured by Applied Medical Resources.
[177966202]
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
[177966203]
Name of procedure being performed: unknown. Detailed description of event: hospital: [name]. "the valve part broke down and dropped off from the center of the cap, when the surgeon inserted the 12 mm kii trocker into the cap during the treatment. As we checked the actual product, it was broken. " [name] has two questions as below: have you had the same product imperfection on the same lot#1361261? If you had before, would you provide us the cause and effect? " patient status: no patient injury. Type of intervention no information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00344 |
| MDR Report Key | 9673919 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-06-25 |
| Date Added to Maude | 2020-02-05 |
| 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 | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | KGW |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-21 |
| Model Number | C8501 |
| Catalog Number | 101357001 |
| Lot Number | 1361261 |
| 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 | 2020-02-05 |