MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CLIP

Model Number HX-610-135

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 title "comparison between endoscopic and laparoscopic removal of gastric submucosal tumor".The literature reported the result of 73 cases of the following procedures using an olympus model single-use reloadable clip (hx-610-135).Endoscopic resection (er) procedures (endoscopic submucosal dissection [esd], endoscopic muscularis dissection [emd], and endoscopic full-thickness resection [eftr]) laparoscopic resections (lr) procedures (laparoscopic endoscopic cooperative surgery [lecs] and laparoscopic wedge resection).In the subject procedures, 3 cases of conversion to laparoscopic surgery and 2 cases of postoperative bleeding reportedly occurred.Based on the available information, a direct relationship between the subject devices and the observed reported adverse events could not be determined.According to the number of adverse events and the number of olympus devices involved in the events, omsc is submitting 5 medical device reports.This is the 1st of 2 reports for postoperative bleeding.

• Brand Name: CLIP
• Type of Device: CLIP
• 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: 9748793
• MDR Text Key: 194873057
• Report Number: 8010047-2020-01485
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HX-610-135
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1