MAUDE Adverse Event Report: UNKNOWN UNKNOWN

Model Number UNKNOWN

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿current status of endoscopic treatment for pancreatic diseases after pancreatoduodenectomy using double balloon endoscopy¿.The literature reported the result of 7 cases of the endoscopic retrograde cholangiopancreatography (ercp) procedures for patients with pancreatic disease after pancreatoduodenectomy using olympus gastrointestinal videoscope model gif-q260j and colonovideoscope model pcf-q260 from october 2013 to november 2018.In the subject cases, 6 cases of acute pancreatitis occurred, but all patients were relieved by conservative treatment.There was no information on which model of the endoscope was used in each procedure.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.There was no information on which model of the endoscope was used in each procedure.Therefore, omsc is submitting mdr according to the number of the adverse events.This is 3rd of 6 reports.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWN
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8715727
• MDR Text Key: 148534724
• Report Number: 8010047-2019-02243
• 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: literature,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2019
• 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