MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number EG-2990I

Device Problems Partial Blockage (1065); Break (1069)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Rest of accessory stuck in operation channel.Operation channel deformed.This event occurred at the time of reprocess.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: the defect parts have been replaced.Correction information: h6: coding changed, based on the investigation result.

• Brand Name: PENTAX
• Type of Device: VIDEO UPPER G.I.SCOPE
• 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: 13270571
• MDR Text Key: 289757948
• Report Number: 9610877-2022-00142
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333129492
• UDI-Public: 04961333129492
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131902
• 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: 06/06/2022

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: EG-2990I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 01/17/2022
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1