MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE ETH2B5LT manufactured by Sterilmed, Inc..
[128409382]
The sterilmed analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. The device history record (dhr) was reviewed and no discrepancies were noted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128409383]
It was reported that a patient underwent a laparoscopic gastric sleeve bypass procedure with a endopath xcel bladeless optiview technology w/stability sleeve and foreign material was present on the obturator tip. The device did contact the patient. However, an alternative device (rpo eth2b5lt) was used to complete the procedure. The intent of the procedure was not altered as a result of the issue and there was no patient consequence. This event has been assessed as reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00112 |
| MDR Report Key | 8095711 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-05-30 |
| Date Added to Maude | 2018-11-21 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2018-11-21 |
| Returned To Mfg | 2018-11-16 |
| Catalog Number | ETH2B5LT |
| Lot Number | 2057644 |
| Device Expiration Date | 2019-05-30 |
| 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 | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-21 |