MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C

Model Number EG-3870UTK

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, " elevator cable showing" involving pentax model eg-3870utk/serial (b)(4).No further information was provided at the time of the report.Pentax service inspectional findings included: distal body chipped, elevator knob play, primary operation channel excess glue at distal end, right/ left brake knob markings faded, up/ down brake knob/ lever markings faded.Fluid invasion in ultrasound connector.Passed wet leak test, lightguide prong cover glass set loose, segment steel braid cut, passed dry leak test, air/ water socket cylinder o-ring chipped, fluid invasion not observed in control body, insertion tube mild compression at stage 1, eus cable single/ long buckled at us connector root brace, corroded ultrasound connector body, right/ left control knob markings faded, ultrasound connector cable, single/ long cracked at end of r, pve electrical connector frame mild corrosion, ultrasound connector lock handle inner lock not engaging, operation channel- primary mild scratch inside, ultrasound warning label cut, elevator washing socket cylinder rubber chipped.Repairs were completed on the device which included replacement of the following components: o-rings and seals, segment staycoil assy pb-free, staycoil collar, insertion flexible tube, operation channel, air/water tube, bending rubber, deflector stay tube assy pb-free, segment assy attaching screw, us connector/junction cable assy pb-free, us connector body pb-free, deflector operting wire, adjusting collar, ud pulley assy, rl pulley assy, angle wire, o-ring (1.8x19.8), warning label, deflector washing socket cylinder.The device was shipped back to the facility on 07/13/2021.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12354081
• MDR Text Key: 283151282
• Report Number: 9610877-2021-00771
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333135899
• UDI-Public: 04961333135899
• Combination Product (y/n): N
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/23/2021

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: EG-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1