MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-09 for NVISIONVLE OPTICAL PROBE 95301-M-20 manufactured by Ninepoint Medical, Inc..
[102065896]
Because the nvisionvle optical probe was not returned, it could not be physically inspected. The device history record was reviewed and no anomalies were identified that could have contributed to this event. The reporter did indicate that the device did not malfunction during the procedure. Related warnings in the instructions for use specify: this device will inflate to labeled diameter and therefore, should not be used in any anatomy where this size would be inappropriate. Strictures, inflammatory disease or esophageal masses may prevent the adequate expansion of the nvision vle optical probe.
Patient Sequence No: 1, Text Type: N, H10
[102065897]
The physician selected a 20 mm nvision optical probe, which contains a 20 mm balloon, for the oct imaging evaluation. Patient presented with bleeding in small area at the proximal end of the patient's 4 cm hernia sac, post the imaging scan. Scan was performed and probe was removed successfully. After probe was removed, using white light endoscopy, a small area of bleeding was noticed. The physician indicated that the tip of the optical marking probe may have caused a small amount of trauma which resulted in the bleeding. The patient procedure was not affected and continued as planned. The bleeding was stopped with hemo-static clips and epinephrine injection at the site. The 20 mm nvision optical probe was inadvertently discarded in the sharps container and could not be evaluated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2018-00001 |
| MDR Report Key | 7328626 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-09 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-09 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2017-09-15 |
| Date Added to Maude | 2018-03-09 |
| 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. MICHAEL JESI |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6172507190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVISIONVLE OPTICAL PROBE |
| Generic Name | NVISIONVLE OPTICAL PROBE |
| Product Code | NQQ |
| Date Received | 2018-03-09 |
| Model Number | 95301-M-20 |
| Catalog Number | 95301-M-20 |
| Lot Number | 005252 |
| Device Expiration Date | 2018-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINEPOINT MEDICAL, INC. |
| Manufacturer Address | 12 OAK PARK DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-09 |