MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for PENTAX VNL-1570STK manufactured by Hoya Corporation Pentax Tokyo Office.
[178958930]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178958931]
The reported complaint was called into pentax medical customer service on 12-dec-2019, and reported biofilm and corrosion found during pre-inspectional check of the endoscope and was documented as "potential endoscope contamination" involving a pentax medical video naso-pharyngo-laryngoscope(npl). No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported. The customer owned video naso-pharyngo-laryngoscope(npl) was received by pentax medical for evaluation on 19-dec-2019. The npl was inspected by pentax medical service on 27-dec-2019, and the following inspection findings were documented: segment crushed, passed dry leak test, short umbilical cable buckle at umbilical connector side, passed wet leak test, pve electrical connector frame mild corrosion. Pentax medical video naso-pharyngo-laryngoscope(npl), vnl-1570stk, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 30-apr-2009. The duodenoscope underwent repairs including the following components: insertion flex tube w/seg pb-free, distal end assy with tube, bending rubber, biopsy inlet t-piece, biopsy inlet barrel, o-rings and seals, insertion/s-nipple attaching screw, o-ring(1. 25x3. 5), suction connection tube, o-ring(1. 2x3. 5). The naso-pharyngo-laryngoscope is pending repair completion, resampling and final qc approval as of 10-jan-2020.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9610877-2020-00016 |
MDR Report Key | 9576942 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-01-10 |
Date of Report | 2019-12-12 |
Date Mfgr Received | 2019-12-12 |
Date Added to Maude | 2020-01-10 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. WILLIAM GOELLER (TEMPORARY) |
Manufacturer Street | 3 PARAGON DRIVE |
Manufacturer City | MONTVALE NJ 07645 |
Manufacturer Country | US |
Manufacturer Postal | 07645 |
Manufacturer Phone | 8004315880 |
Manufacturer G1 | HOYA CORPORATION PENTAX TOKYO OFFICE |
Manufacturer Street | TSUTSUJIGAOKA 1-1-110 |
Manufacturer City | AKISHIMA-SHI, 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-LARYNGOSCOPE |
Product Code | EQN |
Date Received | 2020-01-10 |
Returned To Mfg | 2019-12-19 |
Model Number | VNL-1570STK |
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, 196-0012 JA 196-0012 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-10 |