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

Model Number GF-UCT180

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The scope¿s control body was inspected and found the pink rubber cut, a loose probe and the forceps cover peeling.Deep dents were noted on the scope cover affecting the elevator.The bending section glue was found cracked.Multiple elements were observed to be broken in the ultrasound image.The scope¿s id chip showed 317 uses.The most likely cause for the physical damage is mishandling.The instruction manual states ¿ 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.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed that the scope¿s forcep elevator was broken.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation and additional information from the customer.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed that there was no unevenness.The lm reported that the most probable cause for the reported event is as follows: there is a possibility that some external force was added to the distal end, leading to the peeling of the glue at the tip.It can be seen that some external force was added to the ultrasonic antenna because there was a sound line omission.Since the actual product was manufactured on august 26, 2016, about 4 years and 4 months have passed, it is unclear whether the product was affected by aging degradation or not.There is no generation of this phenomenon caused by products and manufacturing, and there is no problem in the safety.Confirmation of the contents of the instruction manual> ultrasound gastrovideoscope gf-uct180 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. it is not carried out because the product has not been returned yet.

• 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: 11139112
• MDR Text Key: 225798063
• Report Number: 8010047-2021-01111
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341793
• UDI-Public: 04953170341793
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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: 12/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1