PENTAX VSB-3430KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333227686), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K962897); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Partial Blockage; Device Reprocessing Problem; Partial Blockage; Device Reprocessing Problem

  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-20

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173345 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962897. One submission often covers many models, so check the product and lot details in each record.

• Z-2071-2016 · Apr 6, 2016 · Terminated
  Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti