VIDEO GASTROSCOPE EG-2990ZIRecalls & reported problems
Pentax Of America, Inc. · VIDEO GASTROSCOPE VERSION-C (USED) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04961333240166), received between May 15, 2020 and May 15, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
PENTAX MEDICAL BECAME AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2020 IN THE OPERATING ROOM DURING USE IN (B)(6). THE REPORTED COMPLAINT INVOLVED A PENTAX MEDICAL VIDEO UPPER G.I.SCOPE, MODEL EG-2990ZI, SERIAL NUMBER (B)(4). ON (B)(6) 2020, THE USER FACILITY REPORTED BY THE USER FACILITY DIGESTIVE ENDOSCOPY PHYSICIAN STATING THE FOLLOWING: ON (B)(6) 2020, IN THE MORNING SHIFT, I UNDERWENT AN UPPER GASTROINTESTINAL ENDOSCOPY EXAM ON THE PATIENT. THERE WAS NO COMPLICATION DURING THE FIRST MOMENTS OF THE EXAM, THE SAME PROCEEDING ACCORDING TO USUAL MANEUVERS: AFTER THE EVALUATION OF THE FIRST DUODENAL PORTION, PROGRESS WAS MADE TOWARDS THE EVALUATION OF THE SECOND PORTION OF THE DUODENUM. UPON REMOVAL OF THE DEVICE, HOWEVER, THE PRESENCE OF METALLIC MATERIAL IN THE DUODENAL BULB THAT WAS NOT PRESENT AT THE INITIAL INTRODUCTION OF THE ENDOSCOPE WAS OBSERVED. AFTER ANALYSIS OF THE MATERIAL (SMALL CYLINDRICAL ROD WITH A HOLE IN THE TIP), IT WAS DECIDED TO REMOVE IT WITH BIOPSY FORCEPS. THE NEED FOR SUCH A MANEUVER ADDED TIME TO THE EXAMINATION, BUT DID NOT CAUSE FURTHER HARM TO THE PATIENT. AFTERWARDS, IT WAS OBSERVED THAT THE WATER JET FOR CLEANING THE LENSES OF THE ENDOSCOPY DEVICE HAD
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10063017 ↗InjuryMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
PENTAX MEDICAL BECAME AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2020 IN THE OPERATING ROOM DURING USE IN (B)(6). THE REPORTED COMPLAINT INVOLVED A PENTAX MEDICAL VIDEO UPPER G.I.SCOPE, MODEL EG-2990ZI, SERIAL NUMBER (B)(4). ON (B)(6) 2020, THE USER FACILITY REPORTED BY THE USER FACILITY DIGESTIVE ENDOSCOPY PHYSICIAN STATING THE FOLLOWING: ON (B)(6) 2020, IN THE MORNING SHIFT, I UNDERWENT AN UPPER GASTROINTESTINAL ENDOSCOPY EXAM ON THE PATIENT. THERE WAS NO COMPLICATION DURING THE FIRST MOMENTS OF THE EXAM, THE SAME PROCEEDING ACCORDING TO USUAL MANEUVERS: AFTER THE EVALUATION OF THE FIRST DUODENAL PORTION, PROGRESS WAS MADE TOWARDS THE EVALUATION OF THE SECOND PORTION OF THE DUODENUM. UPON REMOVAL OF THE DEVICE, HOWEVER, THE PRESENCE OF METALLIC MATERIAL IN THE DUODENAL BULB THAT WAS NOT PRESENT AT THE INITIAL INTRODUCTION OF THE ENDOSCOPE WAS OBSERVED. AFTER ANALYSIS OF THE MATERIAL (SMALL CYLINDRICAL ROD WITH A HOLE IN THE TIP), IT WAS DECIDED TO REMOVE IT WITH BIOPSY FORCEPS. THE NEED FOR SUCH A MANEUVER ADDED TIME TO THE EXAMINATION, BUT DID NOT CAUSE FURTHER HARM TO THE PATIENT. AFTERWARDS, IT WAS OBSERVED THAT THE WATER JET FOR CLEANING THE LENSES OF THE ENDOSCOPY DEVICE HAD
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10063014 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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