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

Model Number ED34-I10T2

Device Problem Partial Blockage (1065)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

Brush stuck in the op-channel, scope is in poor condition.This event occurred at the time of during inspection.There was no report of patient harm.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.

Manufacturer Narrative

Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary pentax medical emea responded to a good faith effort request via email on november 29, 2023, but was unable to obtain information regarding which company this brush is manufactured by.Based on the data from the investigation, it was determined that the underlying cause/root cause of the failure was a brush that became stuck during equipment reprocessing, rendering the endoscope unusable.A possible cause of the stuckness may be the use of an incompatible brush made by another company, but this has not been determined.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 16-may-2018 under normal conditions.The endoscope was reworked for filter defect including filter replacement and passed required inspections, and was released accordingly.Also, there were no concessions and the dates of approval for shipment and actual date shipped were confirmed for 16-may-2018.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 17831414
• MDR Text Key: 324445109
• Report Number: 9610877-2023-00230
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K192245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1