MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-13 for NVISIONVLE LOW-PROFILE OPTICAL PROBE 95501-LP manufactured by Ninepoint Medical, Inc..
[105756634]
As a result of becoming aware of additional information that was learned through mdr report#3008805841-2018-00003 a review of similar complaints was undertaken. One was identified requiring reassessment of the prior mdr determination, resulting in this report. The nvisionvle? Low-profile optical probe was returned to ninepoint medical for evaluation. Device was intact with the exception of the soft tip which had detached during the procedure. The sheath imaging window did not appear to have been stressed in tension. The device history record was reviewed for the returned nvisionvle? Low-profile optical probe and no anomalies were identified that could have contributed to this event. Investigation is on-going. Related warnings and precautions in the instructions for use include: 1. To prevent failures in the nvisionvle low-profile optical probe, do not kink or sharply bend it at any time. 2. Extreme endoscope manipulations may result in breakage of the optical probe. 3. Do not use the nvisionvle low-profile optical probe if the inner package is open or damaged. 4. Do not use the nvisionvle low-profile optical probe if the device appears to be damaged. 5. The nvisionvle low-profile optical probe is supplied sterile and is designed for single-patient use only. 6. Do not reuse or re-sterilize the nvisionvle low-profile optical probe. 7. This device should not be used in any anatomy where the labeled diameter would be inappropriate.
Patient Sequence No: 1, Text Type: N, H10
[105756635]
The physician selected a nvisionvle? Low-profile optical probe for the oct imaging evaluation. The optical probe was placed inside the common bile duct and imaging was performed successfully. It was reported that the soft tip of the optical probe had become detached inside the endoscope during removal. The physician removed the scope from the patient and removed the optical probe soft tip from the scope. No medical intervention was necessary. The patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2018-00004 |
| MDR Report Key | 7430716 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-02-01 |
| Device Manufacturer Date | 2017-09-15 |
| Date Added to Maude | 2018-04-13 |
| 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 | DR. EMAN NAMATI |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6172507190 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3008805841-04/11/18-001R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVISIONVLE LOW-PROFILE OPTICAL PROBE |
| Generic Name | NVISIONVLE LOW-PROFILE OPTICAL PROBE |
| Product Code | NQQ |
| Date Received | 2018-04-13 |
| Returned To Mfg | 2018-02-01 |
| Model Number | 95501-LP |
| Catalog Number | 95501-LP |
| Lot Number | 5251 |
| Device Expiration Date | 2018-07-31 |
| 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 | 2018-04-13 |