PENTAX EG-2990i (UDI 04961333248179)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04961333248179), received between Jul 19, 2021 and Aug 5, 2021 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K131902); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Leak/Splash; Material Perforation; Material Deformation; Leak/Splash; Material Perforation; Material Deformation

  THIS EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE OPERATION CHANNEL IS BUCKLED BEHIND THE INLET T-PIECE AND LEAKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278861 ↗
• MalfunctionJul 30, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS EVENT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT HARM. PRIMARY CHANNEL BLOCKED. NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250927 ↗
• MalfunctionJul 29, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. THERE IS A BUMP AT DISTAL SIDE OF THE IFT AT 9 CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243733 ↗
• MalfunctionJul 29, 2021Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. IFT LOOSENED, LEAKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243710 ↗
• MalfunctionJul 29, 2021Failure to Disconnect; Failure to Disconnect

  DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. BRUSH STUCK BROKEN IN CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243709 ↗
• MalfunctionJul 28, 2021Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. LCB BROKEN, REDUCED TO 90? / 00?. ROTATABLE LG-PLUG LEAKY, X-RING DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236992 ↗
• MalfunctionJul 28, 2021Leak/Splash; Material Perforation; Detachment of Device or Device Component; Material Split, Cut or Torn; Leak/Splash; Material Perforation; Detachment of Device or Device Component; Material Split, Cut or Torn

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION CHANNEL BUCKLED AT BIOPSY INLET T-PIECE. CHANNEL PERFORATED, LEAKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236988 ↗
• MalfunctionJul 28, 2021Fracture; Fracture

  THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. THE LCB IS BROKEN, SERVICE FOUND OUT, STUFFING ERROR IS THE REASON FOR THE BROKEN LCB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236986 ↗
• MalfunctionJul 28, 2021Fracture; Fracture

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE LCB IS BROKEN / REDUCED (60/80%).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236954 ↗
• MalfunctionJul 24, 2021Gas/Air Leak; Gas/Air Leak

  THE ROTATABLE PLUG IS LEAKY. REASON IS A DEFECTIVE X-RING. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222512 ↗
• MalfunctionJul 24, 2021Circuit Failure; Circuit Failure

  THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. A CUSTOMER WITH A SCOPE EG-2990I, THE PCB RESET BY ITSELF THE CONNECTIONS COUNTER AND SERIAL NUMBER, THE SCOPE IN THE LAST MAINTENANCE HAD 4001 CONNECTIONS AND NOW APPEAR WITH 70 CONNECTIONS. THE SERIAL NUMBER IS (B)(4) AND NOW APPEARS (B)(4), WE ALREADY CONFIGURED THE SERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222502 ↗
• MalfunctionJul 24, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. THERE IS A LEAKING BETWEEN LG CONNECTOR AND ROTATABLE PLUG, CAUSED BY THE DAMAGED X-RING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222458 ↗
• MalfunctionJul 20, 2021Erratic or Intermittent Display; No Display/Image; Deformation Due to Compressive Stress; Erratic or Intermittent Display; No Display/Image; Deformation Due to Compressive Stress

  THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. NO VIDEO IMAGE, FROZEN IMAGE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194416 ↗
• MalfunctionJul 20, 2021Disconnection; Material Split, Cut or Torn; Disconnection; Material Split, Cut or Torn

  OPERATION CHANNEL BUCKLED AT BIOPSY INLET T-PIECE. CHANNEL PERFORATED, LEAKY. THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194400 ↗
• MalfunctionJul 19, 2021Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  THE NOZZLE GET LOST. THE USER FOUND THE NOZZLE DURING THE REPROCESSING. WE ASKED FOR THE REPROCESSING DETAILS. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186984 ↗
• MalfunctionJul 19, 2021Poor Quality Image; Poor Quality Image

  SPOTS IN THE IMAGE. NO PICTURE AVAILABLE. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131902. One submission often covers many models, so check the product and lot details in each record.

• Z-0318-2017 · Aug 15, 2016 · Terminated
  Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forcep
• 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