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 2017-03-07 for ETHCB5LT manufactured by Sterilmed, Inc..
[69282847]
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
[69282848]
It was reported that while the device was in the abdomen, the device had a small portion of the tip split off, not completely separating from the device. The piece was completely retrieved.
Patient Sequence No: 1, Text Type: D, B5
[73593630]
The device was returned for evaluation and was examined having contaminants found that were consistent with patient contact and use in the field. The tip of the device was examined under magnification. The missing portion was not returned and therefore could not be examined. The damage to the tip may have been caused by a heated instrument being pressed against the tip as the damage is jagged rather than smooth, as if partially melted. The root cause was likely linked to the use and potential misuse of the device in the field. If a heated or coagulating device made contact with the plastic tip of the device, the tip could have broken off due to misuse. There are no other structural anomalies present that indicate any additional sections of the device were displaced/separated from the sleeve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2017-00002 |
| MDR Report Key | 6385184 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-07 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-01-29 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2017-03-07 |
| 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 | 2017-03-07 |
| Returned To Mfg | 2017-04-04 |
| Model Number | ETHCB5LT |
| Catalog Number | ETHCB5LT |
| Lot Number | 1961626 |
| Device Expiration Date | 2017-10-31 |
| 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 | 2017-03-07 |