MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GRASPING FORCEPS

Model Number FG-24SX-1

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

Patient Problems No Code Available (3191); Insufficient Information (4580)

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 title "risk factors and consequences of conversion to open surgery in laparoscopic common bile duct exploration".The literature reported the result of 644 cases of the laparoscopic common bile duct exploration procedures using an olympus model chf-v, fg-24x-1 between 2011 and 2017.In the subject procedures, 2 cases of "mortality" and 1 case of "readmission within 30 days", 3 cases of "reoperation" reportedly occurred.Based on the available information, a direct relationship between the subject devices and the observed reported adverse event could not be determined.According to the number of the accidental symptoms known and the number of olympus devices used for procedure, omsc is submitting 6 medical device reports.This is 5 of 6 reports.

Manufacturer Narrative

This is a supplemental report to provide additional information.On july 7, 2021, olympus china sales and marketing (ocsm) could touch with the corresponding author, dr.Wen-yan zheng, and the following was confirmed."there was little relevance between the reported phenomenon and the subject device.".

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9963306
• MDR Text Key: 189201426
• Report Number: 8010047-2020-02223
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• PMA/PMN Number: K955063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FG-24SX-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other