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 2016-08-30 for ETH2B5LT manufactured by Sterilmed, Inc..
[53552161]
The device has not yet been returned to the manufacturer at the time of this report. The device history report was not reviewed and no manufacturing date is available as the lot number provided was incorrect. A supplemental form will be sent once the evaluation is completed if the device is returned or a correction is made to the lot number.
Patient Sequence No: 1, Text Type: N, H10
[53552162]
It was reported that during a laparoscopic gastrostomy sleeve procedure the surgeon found debris inside the device. It was noted that the patient was not harmed and no consequences reported. No extended operation room time was reported, nor did anything fall into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2016-00065 |
| MDR Report Key | 5915975 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-30 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-07-16 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-08-30 |
| 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 | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH 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 | 2016-08-30 |
| Model Number | ETH2B5LT |
| Catalog Number | ETH2B5LT |
| Lot Number | 191834 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-08-30 |