MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C

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  

Event Description

Pentax medical was made aware of a complaint that occurred in the united states.The customer reported "no ultrasound image" involving pentax medical ultrasound video gastroscope, model eg-3670urk, serial number (b)(4).There was no report of death, serious injury or other significant/important medical event.

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.Multiple good faith effort attempts were made with no additional information provided as of 20-nov-2021.The customer owned endoscope was received by pentax medical for evaluation on 22-oct-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint of no ultrasound image and documented the following inspection findings including non-pentax medical parts: ultrasound image noise/ interference, ultrasound image has broken channel, passed wet leak test, umbilical cable non-pentax material, passed dry leak test, insertion tube mild crush at stage 2, customer complaint confirmed, ultrasound connector cable short non-pentax material, ultrasound connector cable root brace rubber body cut/split, ultrasound connector cable non-pentax material, bending rubber gauges/digs.The device underwent repairs including the following components: o-rings and seals, us connector cable body, us connector/junction cable assy pb-free, warning label, us connector body pb-free, o-ring (2x3.3), o-ring specia lfor us connector, light guide cable, suction channel lg, air/water supply tube lg, bending rubber, x-ring(1.8x19.6) gray, gnd wire.Pentax model eg-3670urk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service, but the most recent service did identify non-pentax medical parts.On 04-nov-2021, a device history record(dhr) review for model eg-3670urk, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(6) facility on 26-apr-2011 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 27-apr-2011.The endoscope is awaiting repair and approved by final qc as of 20-nov-2021 and will be returned to the user once completed.

Manufacturer Narrative

Evaluation summary: customer reported no ultrasound image.Therefore, we checked the returned unit and confirmed that the us probe was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the us probe.

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• 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: 12849808
• MDR Text Key: 286267887
• Report Number: 9610877-2021-01442
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/20/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1