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

Model Number TJF-Q180V

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "endoscopic cystogastrostomy: still a viable option in children with symptomatic pancreatic fluid collection".The literature reported the result of pancreatic fluid collections (pfcs) patients who underwent endoscopic cystogastrostomy procedure using olympus "therapeutic duodenoscope (tjf180v)" from june 2013 to december 2017.In the literature, it was reported complication as follows; (1) pfc got infected following the procedure (2 cases); (2) significant bleeding (1 cases); (3) pneumoperitonium (1 case); (4) minor bleeding (5 cases).The literature states the following; significant bleeding which stopped spontaneously.Pneumoperitonium needed unplanned admission for 7 nights.Minor bleeding characterized by oozing from the puncture site.There are not mentioned that these complications were related to the subject device in question.However, omsc assumes that "pfc got infected following the procedure" and "pneumoperitonium" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Therefore, omsc determined that the "pfc got infected following the procedure" and "pneumoperitonium" were adverse event to submit.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Omsc will submit 3 medical device reports (mdr) depending on the number of events.This mdr is the first of three (pfc got infected following the procedure).

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 EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 12768297
• MDR Text Key: 280447977
• Report Number: 8010047-2021-14249
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other