MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-02-14 for NVISIONVLE MARKING PROBE 95301-M-20 manufactured by Ninepoint Medical, Inc..
[67374585]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[67374586]
An nvisionvle marking probe (20mm) was placed through the endoscope into the stomach. During the procedure the balloon was not inflating as quickly as expected, therefore a decision was made to use a new marking probe. The procedure was aborted, and the remaining air was suctioned to deflate the balloon, however the physician prematurely pulled the marking probe back through the endoscope and the balloon detached from the marking probe and lodged in the endoscope channel. The physician decided to advance the scope into the stomach and push the balloon from the endoscope channel using biopsy forceps into the stomach. A snare was used to obtain the balloon from the stomach. The patient was un-harmed, and case completed using the new marking probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2017-00001 |
| MDR Report Key | 6329110 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-02-14 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 2016-11-08 |
| Date Added to Maude | 2017-02-14 |
| 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 MARKING PROBE |
| Generic Name | NVISIONVLE MARKING PROBE |
| Product Code | NQQ |
| Date Received | 2017-02-14 |
| Model Number | 95301-M-20 |
| Catalog Number | 95301-M-20 |
| Lot Number | 004904 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-14 |