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

Model Number HX-110QR

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

The subject device was returned with two clips.The coil sheath of the subject device (clip fixing device) was bent at 460 mm from the distal end.We checked the distal end of the subject device, there was no abnormality such as the deformation.We felt stuck when we pulled the handle of the subject device.The first clip was closed.The clip connector of the first clip was broken.Something biological adhered to the first clip.The second clip was closed.The clip connector of the second clip was not broken.Something biological did not adhere to the second clip.When we put an unused clip on the subject device and we tried clipping, it could be done.However, we needed more force to operate handle for clipping.The manufacturing record was reviewed and found no irregularities.There was a possibility that the clip could not be released because the operation of the slider became heavy and difficult to be pulled out all the way to the end due to such as the bent of the coil sheath.The above device handling has warned in the instruction manual as follows.Do not withdraw the instrument if clipping is not completely finished (when the slider is not pulled out all the way in the proximal direction).Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.

Event Description

We received the following report.During an unspecified procedure, the subject device (clip fixing device) was used.The clip of the subject device could not be released after clipping tissue.The tissue was damaged since the user pulled it with the tissue.A similar event occurred once more in the procedure.The intended procedure was completed with the subject device.There was no patient injury reported.

• 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 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: 8801925
• MDR Text Key: 151418770
• Report Number: 8010047-2019-02588
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170200205
• UDI-Public: 04953170200205
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-110QR
• Device Lot Number: 86K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other