MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ROTATABLE CLIP FIXING DEVICE

Model Number HX-110UR

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined.However, based on the similar reports this type of event is most likely related to the operator's technique.The instruction manual warns user "do not extend the clip abruptly from the distal end of the coil sheath.Also, when pushing the clip out of the coil sheath, keep a sufficient distance between the distal end of the coil sheath and the mucous membrane.If the clip is extended without keeping this distance, the clip may hit against the tissue unintentionally, and perforation, hemorrhage or mucous membrane damage or dropping off of the clip, or break up of the clip may result.

Event Description

Olympus was informed that during a therapeutic right colon mucosectomy with lesion removal procedure, a circular piece of metal broke off from the clip and fell into the patient¿s intestinal lumen.It was reported that several attempts had been made to attach the clip to the patient¿s intestinal wall.It is unknown how the device fragment was retrieved.The intended procedure was cancelled.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.The evaluation was unable to duplicate the reported device issue.Olympus was unable to fully test the reported device as the clip portion was not returned to olympus; however, the rotatable fixing device was inspected and no signs of abnormalities or damages were noted.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from mnd to pkl.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Type of Device: ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6535315
• MDR Text Key: 74166374
• Report Number: 2951238-2017-00318
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PK013066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-110UR
• Device Catalogue Number: HX-110UR
• Device Lot Number: 5ZK
• Other Device ID Number: 04953170200229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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