MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is ongoing to obtain additional information regarding the reported event.The device was returned to the service center for evaluation.The scope¿s control body was inspected and found the probe unit loose, dents and missing glue on the forceps cover.The bending section glue was found cracked affecting the insulation.The bending section braid was noted to be frayed with two broken strands.The glue was noted to be peeling on the cement of the objective and light guide lens.The air/water and suction cylinder were clogged.Further inspection found buckles and scratches on the light guide tube.There was play noted with the scope¿s control knob.Based on the investigation findings, the most likely cause for the reported event is user handling.The instruction gf-uct180 provides the statement below in an effort to mitigate damage to the scope.Do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.

Event Description

The service center was informed that during an unspecified procedure, a defect was noted with the scope¿s channel.It is unknown if the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and device evaluation results.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer confirmed that there were no manufacturing abnormalities, special adoptions, and variations.Via dhr.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: the actual product was manufactured on november 28, 2016, and about 4 years have passed.It was assumed that the control main body was damaged by external force, resulting in loosening.Pathogenesis: from the inspection result of the current product, it has been proven that the indentation has been generated in the control body.Based on the above, it is likely that external force was applied to the control body.In addition, it is considered that the poorly inserted forceps channel in the indicated items may have caused scratches etc.In the forceps channel.The legal manufacturer refers to the ifu chapter 3 preparation and inspection 3.2 inspection of the endoscope.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10895217
• MDR Text Key: 217977159
• Report Number: 8010047-2020-09387
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1