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

Model Number EG-3870UTK

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting (b)(4).Medical device problem code: 2423 obstruction of flow, 2976 material deformation (b)(4) access port.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 3211 deformation problem.Investigation conclusions: 61 unintended use error caused or contributed to event.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint which occurred in the united states within the pai region via a service order repair, that the primary channel was blocked involving pentax medical ultrasound video gastroscope model eg-3870utk, serial number (b)(4).The information indicated that during service inspection, the technician fond sticky residue inside primary operation channel.The primary operation channel was clogged/blocked with organic debris.As this was noted during inspection, it is unknown when the channel became blocked.Cleaning and disinfection, along with angulation adjustment and video image calibration were performed during the service.The customer owned endoscope was previously received by pentax medical for evaluation on (b)(6) 2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented the following inspection findings: insertion tube polyurethane damaged at segment side under the root brace, passed wet leak test, objective lens inner coating deteriorating, suction function low flow, water delivery tube clogged, balloon injection tube clogged (no flow), passed dry leak test, balloon evacuation clogged, eus cable single/ long buckled at us connector root brace, sticky residue inside primary operation channel, ultrasound image has broken channel, image mild spot, operation channel primary clogged/blocked with organic debris, air/ water socket cylinder o-ring chipped, air delivery tube clogged.The device underwent repairs including the following components: o-rings and seals, insertion flexible tube, operation channel, air/water tube, bending rubber, deflector stay tube assay pb-free, segment assay attaching screw, segment attaching screw, distal attaching plate, deflector operating wire, adjusting collar, angle wire, objective cover lens, objective prism assay, warning label.The endoscope is awaiting repair completion and approved by final qc as of (b)(6) 2021.Model eg-3870utk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On (b)(6) 2021, a device history record (dhr) review for model eg-3870utk, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(6) facility on (b)(6) 2014 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 (b)(6) 2014.This event meets the requirement for fda reportability; therefore submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

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).

• 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
• 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: 12618911
• MDR Text Key: 284019259
• Report Number: 9610877-2021-01022
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333135899
• UDI-Public: 04961333135899
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1