MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LONG CLIP

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

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 Description

On october 2, 2020, olympus medical systems corp.(omsc) received literature titled "comparison of long-term outcomes between endoscopic band ligation and endoscopic clipping for colonic diverticular hemorrhage".This study was conducted endoscopic band ligation and endoscopic clipping for 100 patients of colonic diverticular hemorrhage between january 2004 to november 2014.The subject device was used during the endoscopic clipping procedure.In the literature, it was reported that complications of 47 cases of bleeding have occurred.21 cases of 47 the bleeding were conservatively managed by medical therapy.8 cases of 47 the bleeding were managed by applying endoscopic band ligation, and 13 cases of 47 the bleeding were managed by applying endoscopic clipping.3 cases of 47 the bleeding were needed transarterial embolization (tae) due to uncontrolled bleeding.2 cases of 47 the bleeding were needed surgery.One of the surgery was the right hemicolectomy that not due to uncontrolled bleeding.One of the surgery was performed due to uncontrolled bleeding.There are no descriptions of device relevance for all adverse events in the literature.There is no description of the device's malfunction.Based on the available information, detailed information of the subject device was not provided.Whereas, omsc assumes that 4 cases of the bleeding needed to surgery and tae were related to the subject device due to occurred during the procedure.Therefore, omsc will submit a medical device report (mdr) for the bleeding needed to surgery and tae.

• Brand Name: LONG CLIP
• Type of Device: LONG 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: 10739935
• MDR Text Key: 213186717
• Report Number: 8010047-2020-08180
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963160
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• 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
• Patient Outcome(s): Other