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

Model Number GIF-H260

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

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

On jan.5, 2022, olympus medical systems corp.(omsc) received the literature titled "long-term outcome of endoscopic balloon dilation for duodenal crohn¿s disease-associated strictures".In the literature, fifty-four patients with duodenal cd-associated strictures who underwent ebd between june 2011 and may 2020 were included.The median age of the patients was 28.31±8.30 years, and 44 patients were male.For the procedure, olympus products(gif-h260) were used.In the literature for the procedure, it was reported that the following.Two patients who had excruciating pain in the belly after dilation were diagnosed with duodenal perforation based on abdominal ct.One patient was cured by conservative treatment, and another patient who failed conservative treatment underwent surgery.Based on the available information, reported perforation was not reported in a direct relationship with the olympus products.However, omsc assumes that the perforation might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the perforation (1 patient) might be caused or contributed to a death or serious injury.Omsc assumes that the perforation (1 patient) was not serious based on the available information such as the following report: one patient was cured by conservative treatment.Therefore, omsc assumes that the perforation was an adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the perforation.

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

• 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: 13363922
• MDR Text Key: 287018988
• Report Number: 8010047-2022-02052
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: GIF-H260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention