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 2016-08-24 for ETH2B5LT manufactured by Sterilmed, Inc..
[52946625]
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
[52946626]
It was reported that during a procedure, debris was found in two trocars. It was reported that no adverse events experienced and no patient injury or consequences were noted. (see mfr report# 2134070-2016-00060 as the first device was reported).
Patient Sequence No: 1, Text Type: D, B5
[55220983]
The device was returned to the manufacturer and examined. A single piece of debris was able to be extracted from the inside of the cannulated obturator. The debris was found to be dark in color, though it did not exhibit characteristics of organic debris. As the attached images show the debris curls upon itself instead of breaking or flaking apart. The debris's origin is unknown, though it may have been knocked loose or cut loose from the black plastic that composes the handle of the obturator when the device was used in the field. Based upon the appearance of the debris, it is likely the same debris that the account photographed in its attachments to this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00061 |
| MDR Report Key | 5901637 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-24 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-07-27 |
| Date Mfgr Received | 2016-09-20 |
| Device Manufacturer Date | 2016-04-29 |
| Date Added to Maude | 2016-08-24 |
| 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 | 2016-08-24 |
| Returned To Mfg | 2016-09-20 |
| Model Number | ETH2B5LT |
| Catalog Number | ETH2B5LT |
| Lot Number | 1917834 |
| Device Expiration Date | 2017-04-29 |
| 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 | 2016-08-24 |