MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SMBOWEL ENTEROSCOPE

Model Number VSB-3430K

Device Problems Partial Blockage (1065); Device Reprocessing Problem (1091)

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

The user facility contacted pentax medical customer service on (b)(6) 2021 for an endoscope that "cannot pass accessory to inlet port,and customer stated can't pass cleaning brush on biopsy channel" involving pentax medical smbowel enteroscope model vsb-3430k, serial number (b)(4).Three good faith effort(gfe) attempts were made with no response from the user facility.The customer owned colonoscope was returned to pentax medical for evaluation on 14-jun-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customers experience when they found a "check valve stuck inside biopsy inlet t-piece" and documented the following inspection findings on 15-jun-2021: umbilical cable bump at pve side, passed dry leak test, passed wet leak test.During qc testing the "ground terminal fail biopsy inlet continuity test" on 29-jun-2021.The device underwent repairs including the following components: bending rubber, adjusting collar, ud pulley assy, rl pulley assy, angle guide, o-rings and seals.Model vsb-3430k, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 07-aug-2017.The instructions for use (ifu) for reprocessing of pentax video colonoscope instructs the user to detach the water jet check valve and reprocess separately from the colonoscope.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.The endoscope is awaiting repair and approved by final qc as of 15-jul-2021.

Manufacturer Narrative

Evaluation summary: this is an event in which a check valve attached to a component of an endoscope clogs the aspiration line.The cause is thought to be that the check valve that got into the washing machine during the washing process clogs the pipe with the water flow.

• Brand Name: PENTAX
• Type of Device: SMBOWEL ENTEROSCOPE
• 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: 12173345
• MDR Text Key: 280569595
• Report Number: 9610877-2021-00145
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333227686
• UDI-Public: 04961333227686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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: VSB-3430K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1