MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO PROCESSOR

Model Number EPK-I5010

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint on 24-jun-2021 that occurred in the united states.The reported complaint of "no video image" involving pentax medical video processor, model epk-i5010, serial number (b)(4).The user facility responded to good faith efforts(gfe) via email on 28-jun-2021 and stated that the no video image occurred during the pre-inspection check and that the endoscope was removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement and that they follow the ifus for reprocessing and accessories.No additional information was provided.The customer owned processor was received by pentax medical for evaluation on 30-jun-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented the following inspection findings on 02-jul-2021: process pcb digital video failure, limit switch actuator plate(2) bent, scope connector handle loose, control panel unit button not functioning.The device underwent repairs including the following components:cable to limit sw, pcb for process ntsc (rohs complied).This is the first time pentax model epk-i5010, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service on 17-sep-2015.The endoscope wasrepair and approval by final qc on 21-jul-2021 and delivered to the customer under delivery order (b)(4).

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: g6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result (health effect - clinical code,health effect - impact code).

• Brand Name: PENTAX
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12222635
• MDR Text Key: 282280174
• Report Number: 9610877-2021-00268
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPK-I5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/24/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1