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

Model Number HX-202UR

Device Problem Difficult to Open or Close (2921)

Patient Problems Hematoma (1884); Tissue Damage (2104)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

The referenced clip was not returned to olympus for evaluation.The cause of the reported event could not be determined.However, based on similar reported events related to the reported device, the operator¿s technique cannot be ruled out as a contributory factor.The instruction manual provides warning to mitigate the risk of patient injury and device damage that states, keep the insertion portion of the instrument that extends from the biopsy valve and the insertion portion of the endoscope as straight as possible.Do not perform clipping with the insertion section being coiled.Otherwise, the force exerted on the control section may not convey to the clip adequately during clipping.This could result in reduced performance, making it impossible to close the clip or detach it from the coil sheath after clipping.When forcing the clip against the tissue, do not try to rotate the clip.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.Do not perform repositioning more than the limitation (5) of reopening times.The clip may fail to open while it is grasping the tissue.This may result in impaction or prevent to re-open.If the clip cannot re-open, complete clipping according to step 7 and 8 described on page 9 and 10 and withdraw the instrument from the endoscope.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a polypectomy procedure, the patient sustained moderate tissue trauma and a small hematoma at the edge of the polypectomy site.The user facility reported that a moderate sized polyp was clipped; however, the device would not stay closed after deployment.There were no difficulties or resistance inserting the device into the endoscope.Due to the clip failure the procedure was delayed 10 minutes.Additional clips from a different lot were placed at the site and the intended procedure was completed.No other additional medical or surgical intervention was needed.The patient's current condition is fine.This is 2 of 2 reports.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8380742
• MDR Text Key: 137558288
• Report Number: 2951238-2019-00481
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• 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: 88K-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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
• Treatment: HX-202UR/LOT # 88K-06
• Patient Outcome(s): Other