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

Model Number EG-3670URK

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an event on 11-jun-2021 that occurred in the united states.The customer complained of no video image, involving a pentax medical ultrasound video gastroscope, model eg-3670urk, serial number (b)(4).Good faith effort(gfe) attempt were sent via email with no responses.The customer owned colonoscope was received by pentax medical for evaluation on 18-jun-2021.The colonoscope was inspected by pentax medical service under service order (b)(4) and the technician was unable to duplicate the users complaint and documented the following inspection findings on 21-jun-2021: eus cable single/ long buckled at junction root brace, insertion tube bump at stage 1, passed wet leak test, ultrasound connector cable dent/ crush, passed dry leak test, pve connector housing scratched, ultrasound image has broken channel, eus cable long buckled at control body root brace, control body grip scratched, insertion tube buckles at stage 1.Although the loss of image was not duplicated, the colonoscope underwent repairs including the following components: o-rings and seals, insertion flexible tube, air/balloon return tube, a/w/operation channel, bending rubber, adjusting collar, ud pulley assy, rl pulley assy, angle wire, pcb for ccd k3a pb-free/ntsc, electricl connector assy.Model eg-3670urk, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 28-may-2014.The endoscope is awaiting repair and approved by final qc as 11-jul-2021.

Manufacturer Narrative

Correction information: g6: follow up #1.H2: if follow-up, what type? h6: coding changed based on the investigation (health effect - clinical code, health effect - impact code).Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12148224
• MDR Text Key: 281747674
• Report Number: 9610877-2021-00197
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333123360
• UDI-Public: 04961333123360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

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-3670URK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/11/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1