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

Model Number EG-2990I

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, "broken inlet port" involving pentax model eg-2990i/serial (b)(4).No further information was provided at the time of the report.Pentax has made 3 good faith effort attempts to collect additional information from the facility.No further information has been received to date.The device was returned to pentax.Pentax service inspectional findings included: primary operation channel hole, leak at biopsy channel (large/ primary) distal side, failed wet leak test, endoscope failed electrical safety test - hi-pot, pve electrical connector frame has severe corrosion, failed dry leak test, fluid invasion in segment section, fluid invasion to insertion tube, operation channel- primary slice by accessory, control body mild corrosion inside, mild moisture in control body, control body grip cracked forward body cover cracked.Repairs were performed on the device which included replacement of the following components: o-rings and seals, distal end assy with tubes, adjusting collar, bending rubber, distal attaching plate, segment assy attaching screw, insertion flex tube, segment attaching screw, staycoil collar, segment staycoil assy pb-free, rl pulley assy, ud pulley assy, electrical connector assy, pcb for ccd drive pb-free, fwd body trim collar, body cover grip.The device was shipped back to the facility on 07/26/2021.

• Brand Name: PENTAX
• Type of Device: HD 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 goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12354477
• MDR Text Key: 267714412
• Report Number: 9610877-2021-00766
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333129492
• UDI-Public: 04961333129492
• 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
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1