MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-06 for NVISIONVLE OPTICAL PROBE 95101-20 manufactured by Ninepoint Medical, Inc..
[48856054]
The nvisionvle optical probe was returned for evaluation in multiple pieces, with the balloon detached. Per the initial reporters' statement from the procedure, the nurse prematurely tried to pull the optical probe through the endoscope prior to deflation completing, detaching the balloon. Within the precautions of the nvisionvle optical probe instructions for use it states "when drawing the optical probe into the endoscope, if pillowing is observed, stop and either reinflate and deflate, or remove the optical probe and scope as a system. "
Patient Sequence No: 1, Text Type: N, H10
[48856055]
An nvisionvle optical probe (20mm) was placed through the endoscope into the stomach. During the procedure the balloon was not holding pressure as designed. The procedure was aborted, and the remaining air was suctioned to deflate the balloon, however the nurse prematurely pulled the optical probe back through the endoscope and the balloon became lodged at the opening of the endoscope channel. Excessive force used by the nurse ripped the balloon off the catheter leaving it in the esophagus. Biopsy forceps were used to retrieve the balloon from the esophagus. Patient was un-harmed, the airway was not occluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2016-00002 |
| MDR Report Key | 5772349 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-06 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2016-06-08 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2016-07-06 |
| 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 | MS. HEATHER REED |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6172507141 |
| Manufacturer G1 | NINEPOINT MEDICAL, INC. |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| 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 | 2016-07-06 |
| Returned To Mfg | 2016-06-22 |
| Model Number | 95101-20 |
| Catalog Number | 95101-20 |
| Lot Number | 004777 |
| Device Expiration Date | 2017-04-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-07-06 |