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

Model Number	FG-8U-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
On february 15, 2021, olympus medical systems corp.(omsc) received the literature titled "endoscopic full-thickness resection with defect closure using clips and an endoloop for gastric subepithelial tumors arising from the muscularis propria".This study was conducted on the endoscopic full-thickness resection (eftr) for 51 patients with gastric subepithelial tumors arising from the muscularis propria from january 2009 to december 2012.In the literature, it was reported that one minor bleeding and one tumor fell into the peritoneal cavity during the procedure.The minor bleeding was successfully managed by endoscopic means.However, in the case of the tumor fell into the peritoneal cavity, the procedure was converted into a laparoscopic resection.Omsc assumes that the reported events might be related to the subject device since the subject device was used for the eftr.Therefore, omsc assumes that the event converted into a laparoscopic resection was an 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 one medical device reports (mdr) of the subject device for the adverse event of the conversion into a laparoscopic resection.

• Brand Name: GRASPING FORCEPS
• Common Device Name: 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: 11408492
• Report Number: 8010047-2021-03267
• Device Sequence Number: 4053327
• Product Code: EOQ
• UDI-Device Identifier: 04953170031519
• UDI-Public: 04953170031519
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: FG-8U-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention