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

Model Number HX-610-090L

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to omsc for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by a health care professional that a strangulation ileus occurred after an unspecified procedure using the subject device (clip).The user facility doubted that clipping not only the tissue of small intestine but also the other parts caused the strangulation ileus.The patient needed a surgical intervention for the strangulation ileus.

Manufacturer Narrative

Correction to b1, please see b1 for further information.Correction to g3 of the initial medwatch.The aware date should be 07-oct-2021.Correction to g2 to add the foreign country japan.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the production lot number and manufacturing date were unknown, the following dhrs for one year (november 2020 to october 2021) from the date of receipt of the report were confirmed, and the inspection items related to the indicated event were reviewed.There was no abnormality.Repeated attempts were made to obtain the device for further testing and evaluation as well as requests for additional information however, those request were unsuccessful.Because the device was not returned and based on the results of the investigation, a root cause could not be determined.The following is included in the device instructions for use (ifu): - "do not press the clip against the tissues in the body cavity with excessive force.This may lead to perforation, major bleeding, mucosal damage, etc." - "this product is intended for use by doctors or medical professionals under the supervision of a physician, and it is assumed that the user will receive sufficient training on the part of the user for the clinical procedure of endoscopy.Therefore, this instruction manual does not touch on matters related to clinical procedures for endoscopy.The details of the clinical procedure of endoscopy should be judged from the standpoint of each specialty." olympus will continue to monitor field performance for this device.

• 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: 12735917
• MDR Text Key: 279644473
• Report Number: 8010047-2021-13947
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-610-090L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention