MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ

Model Number VSB-3430K

Device Problems Complete Blockage (1094); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, "cannot pass accessory to inlet port - cannot pass cleaning brush in biopsy channel" involving pentax model vsb-3430k/serial (b)(4).No further information was provided at the time of the report.The device was returned to pentax.Pentax service inspectional findings included: check valve stuck inside biopsy inlet t-piece, umbilical cable bump at pve side, passed dry leak test, passed wet leak test, ground terminal fail biopsy inlet continuity test.Pentax has made 3 good faith effort attempt to collect additional information from the facility.No further information has been received to date.Repairs were performed on the device which included replacement of the following components: bending rubber, adjusting collar, ud pulley assy, rl pulley assy, angle guide, o-rings and seals.The device was shipped back to the facility on 07/15/2021.

• Brand Name: PENTAX
• Type of Device: SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12357109
• MDR Text Key: 283158007
• Report Number: 9610877-2021-00770
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K962897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1