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

Model Number ED34-I10T

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not registered in the us, however a similar device is sold and marketed in the us, the 510k for that device is: k163614.The device was not returned to pentax medical, as such the reported event could not be confirmed or further clarified, no a cause determined.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical was made aware of an event that occurred in the asia pacific region involving pentax model ed34-i10t video duodeno scope.The user stated the following: during installation after unboxing "check scope connection [no.05]" error message pops up while connecting the scope with the epk-i7010 processor while distorted parallel lined image is advent in epk-i5000.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENSOSCOPE
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12354626
• MDR Text Key: 267758508
• Report Number: 9610877-2021-00576
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: NP
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2021

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: ED34-I10T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1