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

Model Number EG29-I10

Device Problem No Display/Image (1183)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, " no video image" involving pentax model eg29-i10/serial (b)(4).No further information was provided at the time of the report.Pentax made 3 good faith effort attempts to confirm initial details and collect additional information from the facility.No additional information has been received.The device was returned to pentax medical for evaluation.Pentax service inspectional findings included: image blackout, distal body chip at channel opening at thinnest part, passed wet leak test, suction tube resistance, passed dry leak test, insertion tube buckles under the root brace, pve connector housing scratched, insertion tube root brace broken, air/ water nozzle glue worn, remote control button cover #1 rc button is partially cracked, insertion tube root brace cut.Repairs are being performed on the device which will include replacement of the following components: o-rings and seals, insertion flexible tube assy, distal end assy with tubes, rl pulley assy, ud pulley assy, bending rubber, adjusting collar, angle wire, light guide fiber bundle, shield pipe for ccd, signal wire for ccd pr-free, pcb for ccd drive pb-free, electrical connector assy, x-ring(1.8x19.6) gray, suction channel lg.

Manufacturer Narrative

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

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12457503
• MDR Text Key: 283603319
• Report Number: 9610877-2021-00631
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1