MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-31 for ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE ETH2B5LT manufactured by Sterilmed, Inc..
[131770265]
The bwi failure 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. Date of event: the event date is unknown. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131770266]
It was reported that a patient underwent a laparoscopic procedure with a endopath xcel bladeless optiview technology w/stability sleeve and the physician noted tissue debris inside the device. The device did contact the patient. There was no patient consequence. This event has been assessed as reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00117 |
| MDR Report Key | 8207018 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-10 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2018-12-31 |
| 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 | 3 |
| Brand Name | ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2018-12-31 |
| Returned To Mfg | 2018-12-26 |
| Catalog Number | ETH2B5LT |
| 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 | 2018-12-31 |