MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q180

Device Problems Partial Blockage (1065); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to service center for evaluation.The gif-q180 scope was inspected and partially confirmed the customer¿s complaint of a ¿channel blockage.¿ the channel was found to have severe tear marks and damage.In addition, there are multiple leaks and a cracked light guide lens.The most likely cause for the physical damage is mishandling.Warnings and cautions: 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.4.2 using endotherapy accessories: if insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.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 during an unspecified procedure, the user reported an obstruction, "bubbles when finger is not on valve" and foreign material exiting the 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 additional information received.Please see the updates in sections: g4, g7, h2 and h10.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11142103
• MDR Text Key: 226074221
• Report Number: 8010047-2021-01136
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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
• Device Model Number: GIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1