MAUDE Adverse Event Report: OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS GIF-H190 GASTROSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND, SPECTRUM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  malfunction  

Event Description

The distal oblique attachment mh-588 tip for the olympus gif-h190 gastroscope (b)(4) is noted to clip in use which can result in risk of dislodgement during the procedure.Add'l measures to secure have been noted by physician.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS GIF-H190 GASTROSCOPE
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND, SPECTRUM
• Manufacturer (Section D): OLYMPUS SURGICAL TECHNOLOGIES AMERICA
• MDR Report Key: 8711942
• MDR Text Key: 148475398
• Report Number: MW5087429
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR