MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS EVIS EXERA II; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number GIF-Q180

Device Problem Device Inoperable (1663)

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

Event Date 06/17/2017

Event Type  malfunction  

Event Description

Prior to the case start, the scrub tech and i checked the functionality of the upper endoscopy (egd) scope.When dr.Was about to use the egd scope intra-operatively, it was not functioning properly anymore.We tried to contact the endoscopy department to borrow egd scope but it was already closed and no staff was around.We had to ask help from the security guard and supervisor so that we can get in and borrow egd scope.It took probably 30 minutes of waiting before dr.Was able to proceed with the case.This is an unexpected malfunction of the egd scope that action could not have been planned.The rn took the correct action, however, it still delayed the patient's treatment.No harm was done, just a delay.Biomed sent scope to medical optics for repair.Repair completed by medical optics, tested and returned to service.The following repairs were completed: alignment of image (required w.Ccd video chip) ; adjust angulations (required w.Ccd video chip) ; replace bending rubber (required w.Ccd video chip) ; replace biopsy channel (required w.Ccd video chip) ; repair ccd video chip (no image).

• Brand Name: EVIS EXERA II
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 6766973
• MDR Text Key: 81814936
• Report Number: 6766973
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: GIF-Q180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.; UNKNOWN,
• Patient Age: 60 YR