MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-09-28 for ETH2B5LT manufactured by Sterilmed, Inc..
[55808763]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[55808764]
It was reported that while performing the medical procedure, debris was found in the trocar. There was no injury or consequence to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[58747599]
The device was returned to the manufacturer and examined. While no debris was found to be present in the obturator at the time of the investigation, debris was found and examined in the bag that the device was returned in. The debris did not display any characteristics consistent with organic debris but appeared to be some sort of plastic. The pictures returned from the account confirm that debris was present in the obturator during use in the field. Origin unknown
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00069 |
| MDR Report Key | 5983152 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-09-28 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-16 |
| Date Mfgr Received | 2016-10-28 |
| Device Manufacturer Date | 2016-04-22 |
| Date Added to Maude | 2016-09-28 |
| 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 | JASON ANDERSON |
| Manufacturer Street | 11400 73RD AVE N |
| Manufacturer City | MAPLE GROVE MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2016-09-28 |
| Returned To Mfg | 2016-10-28 |
| Model Number | ETH2B5LT |
| Catalog Number | ETH2B5LT |
| Lot Number | 1918455 |
| Device Expiration Date | 2017-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-28 |