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

Model Number GIF-2TQ260M

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp (omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

On june 13th, 2019, olympus medical systems corp.(omsc) received a literature titled ¿results of duodenal stent for the pancreatic carcinoma and the duodenal stenosis¿.The literature reported the result of 10 cases of the duodenal stent replacement for the duodenal stenosis caused by the pancreatic carcinoma using an olympus gastrointestinalscope (gif-2tq240) or an olympus duodenoscope (tjf-260v) or olympus gastrointestinalscope (cf-h290zi) between april 2012 and february 2019.It was reported that gif-2tq240 was used in 8 cases, tjf-260v and cf-h290zi were used in 1 case each in the literature.However, the model numbers of gif-2tq240 and cf-h290zi described in the literature do not exist.Based on the sales history for the user facility, it is surmised that the literature meant gif-2tq240 as gif-2tq260m.Olympus couldn't identify what is the correct model number of cf-h290zi even after reviewing the sales history.In the subject procedures, 2 cases of cholangitis and 1 case of suspected duodenal perforation reportedly occurred.It was reported that supportive care was provided to all patients.Based on the available information, a direct relationship between the olympus device and the observed adverse events could not be determined.Omsc is submitting 9 medical device reports according to the number of the adverse events known and the number of olympus device used for procedure.This is a report on 1 of 2 cases of cholangitis regarding gif-2tq260m and 1 of 9 reports.

• Brand Name: EVIS LUCERA 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8769978
• MDR Text Key: 150389480
• Report Number: 8010047-2019-02432
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-2TQ260M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other