MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-23 for PENTAX VNL-1190STK manufactured by Hoya Corporation Pentax Tokyo Office.
[75827429]
(b)(4). Mdrs 9610877-2017-00027, 9610877-2017-00030, 9610877-2017-00031, 9610877-2017-00032, and 9610877-2017-00033 are being submitted for the 5 patients. Pentax video naso pharyngo laryngostroboscope product code is class 1, exempt from pma/510(k).
Patient Sequence No: 1, Text Type: N, H10
[75827430]
Pentax medical was made aware of a report stating a patient experienced an allergic reaction during a procedure with a pentax endoscope. No further information on the patient or the endoscope was provided at the time of the report. A meeting was held with the facility on 04/25/2017 in which the facility stated several incidences have occurred during procedure with pentax video naso pharyngo laryngostroboscope model vnl-1190stk/serial number (b)(4). The instances have been occurring more frequently which prompted the facility to notify pentax. The events were described as follows: it was observed, down the nasal cavity and back into the nasal pharynx, that patients were experiencing reactions (thermal/chemical injuries/burns to the tissues). Patients have had to go to the er to receive treatment. In addition, during the meeting, the facility stated the instructions for use for this model endoscope is followed meticulously and there have been no issues with this endoscope since acquisition in 10/2013. The endoscope was removed from use after the event occurred on (b)(6) 2017 and sent into pentax for evaluation. The pentax medical inspection findings included the following: -fluid invasion in segment section. -image alignment out. -vertical lines in image. -failed wet and dry leak test. -segment steel braid twisted. -up/down control knob/lever tension. -insertion tube severe coil shifting at stage 1. -bending rubber pinhole. -segment corroded. -video image has a white or red dot. -up angulation decreased. -bending rubber loose. -insertion tube buckles at stage 1. -insertion tube severe discoloration at stage 1. In addition, a dielectric strength test (the ability for the device to handle over voltage) and a patient leakage current test were performed (voltage going from endoscope to patient). The endoscope did fail ds test. The plc test was higher than normal but did not fail the test. Repairs were performed on the endoscope which included replacement of the following components: -o-rings and seals. -distal end w/ccd-m pb-free/ntsc usa. -distal attaching pin. -insertion flex tube w/seg pb-free. -bending rubber. The device was returned to the customer on 05/08/2017. Additional information was received from the facility on 05/16/2017 indicating 5 patients experienced adverse reactions during procedure with the device identified in this mdr. A separate mdr is being submitted for each patient. The event details related to the patient identified in this mdr are as follows: topical anesthetic was applied to l nares. Distal chip scope was passed transnasally on left approx 850 am. Videostrobe exam completed. Patient's spouse called around 930 am-945 am reporting to ma that patient was having an allergic reaction to strobe with hives and itching, but no difficulty breathing. Spouse gave patient benadryl 10 minutes prior. Ma consulted slp. Slp indicated patient's spouse should call rescue 911 / proceed to emergency room. Md in office at time was advised of situation. The patient was seen in the emergency department. Follow up for the patient was described as routine and ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2017-00031 |
| MDR Report Key | 6586139 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-23 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-01-27 |
| Date Facility Aware | 2017-04-24 |
| Report Date | 2017-05-23 |
| Date Reported to FDA | 2017-05-23 |
| Date Reported to Mfgr | 2017-05-23 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-23 |
| 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. MATTHEW VERNAK |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 2015712300 |
| Manufacturer G1 | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Street | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI |
| Manufacturer City | TOKYO, 196-0012 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-0012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE |
| Product Code | EQL |
| Date Received | 2017-05-23 |
| Returned To Mfg | 2017-04-27 |
| Model Number | VNL-1190STK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Address | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI TOKYO, 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-05-23 |