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

Model Number EG-3270UK

Device Problem Obstruction of Flow (2423)

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 that occurred in the united states.The information provided indicated that the suction channel was blocked involving a pentax medical ultrasound video gastroscope model eg-3270uk, serial number (b)(4).The customer stated there was an internal leak inside the channel.Good faith efforts(gfe) emails have been sent.No additional information has been provided.The customer owned endoscope was received by pentax medical for evaluation on 02-aug-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and during quality inspection the technician confirmed the customers experience as the "operation channel- primary slice by accessory" was identified and also documented the following inspection findings: leak at biopsy channel (large/ primary) distal side, failed wet leak test, failed dry leak test, suction tube mild resistance, ultrasound warning label cut, suction function not performed unit compromised, operation channel- primary slice by accessory, fluid invasion not observed in pve connector, fluid invasion not observed in control body.The device underwent repairs including the following components: o-rings and seals, bending rubber, operation channel, suction channel lg, warning label.Model eg-327uk, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service.The endoscope was approved by final qc on 19-aug-2021 and delivered to the customer under delivery order (b)(4).

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• 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: 12373950
• MDR Text Key: 283244551
• Report Number: 9610877-2021-00663
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333233793
• UDI-Public: 04961333233793
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3270UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1