NA Quick Connect (REF QPC3005E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995162566), received between Jan 15, 2021 and Jan 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K090036, K101409, K102462, K113520, K131078, K161683, K170956, K173256, K180342, K182827, K190104, K191343, K192929, K210737, K211607, K222615, K230582, K232914, K251666); 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.

• MalfunctionJan 15, 2021Partial Blockage; Failure to Disconnect; Device Damaged by Another Device

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2020 UNDER RMA NOTIFICATION (B)(4) FOR AN "ACCESSORY STUCK IN SCOPE", INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG-3670URK, SERIAL NUMBER (B)(4) AT (B)(6) HOSPITAL. THE REPORTER ALSO STATED THAT THE EVENT OCCURRED DURING THE PROCEDURE ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED. THE USER FACILITY USED A TAPERED TIP CATHETER DURING THE PROCEDURE. THE USER FACILITY REPLIED VIA EMAIL TO A GOOD FAITH EFFORT EMAIL ON 22-DEC-2020, STATING THE CATHETER WAS A BOSTON SCIENTIFIC RAPID EXCHANGE TAPERED TIP XL CANNULA REF #M00545820. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 22-DEC-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER 3130641, THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 29-DEC-2020: BIOPSY INLET T-PIECE STUCK ACCESSORY AT AFT TUBE, SUCTION TUBE RESISTANCE, ULTRASOUND IMAGE NOISE/ INTERFERENCE, RESIDUE ON AIR/WATER SOCKET, LEAK AT CONTROL BODY, CONTROL BODY CRACKED FROM SIDE BODY COVER AT PROXIMAL END, FAILED DRY L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11179943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090036, K101409, K102462, K113520, K131078, K161683, K170956, K173256, K180342, K182827, K190104, K191343, K192929, K210737, K211607, K222615, K230582, K232914, K251666. One submission often covers many models, so check the product and lot details in each record.

• Z-1180-2016 · Dec 4, 2015 · Terminated
  Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapt
• Z-0616-2014 · Nov 21, 2013 · Terminated
  SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the
• Z-1596-2013 · Mar 4, 2013 · Terminated
  Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Re
• Z-2284-2012 · Aug 10, 2012 · Terminated
  QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
• Z-2335-2012 · Aug 1, 2012 · Terminated
  The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible
• Z-0869-2012 · Dec 7, 2011 · Terminated
  STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to
• Z-3124-2011 · Aug 11, 2011 · Terminated
  SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liqu
• Z-1960-2011 · Mar 14, 2011 · Terminated
  STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manual