MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported by the customer, during an unspecified therapeutic procedure using single use repositionable clips, after the clip was applied, the clip failed to release.A second clip was used and failed as well.Excessive force was used to attempt to release the clips, the patient experienced a tissue tear as a result of these events.The tear was managed with a clip (brand and model number not provided), and the procedure was completed.Case with patient identifier (b)(6) reports the first clip that failed.Case with patient identifier (b)(6) reports the second clip that failed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s final investigation.The exact cause of the reported phenomenon could not be conclusively identified due to the following reasons: no device was returned to olympus for evaluation and a review of the device history record (dhr) revealed no problem detected during the manufacturing of the device.Based on the event description and mechanism of the subject device, it is possible that the clip did not detach due to the following reasons: slider not fully pulled back, damage of the limiter, the endoscope or subject device was pulled while the clip was grasping the tissue, the slider was not pushed forward to release the clip.It is possible that the tissue was torn due to the following mechanisms: the clip was not separated from the sheath, device was pulled due to handling such as withdrawing the instrument forcibly or changing the angulation of the endoscope and the clipped tissue was pulled by handling.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL 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: 12557865
• MDR Text Key: 274297912
• Report Number: 8010047-2021-12524
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 05K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 06/30/2022
• 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; Other