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

Model Number HX-202UR

Device Problems Positioning Problem (3009); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

Insufficient information regarding the reported event was provided by the user facility as multiple follow-ups were made to obtain additional information but with no results.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 therapeutic procedure, the device has an issue deploying from the sheath.After manipulating the device, the device deployed but did not stay clipped to the patient¿s tissue.It is believed the device fell into the patient as it was reported the user facility decided not to retrieve the device.There was no patient injury reported.No additional information was reported.

• 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: 8167006
• MDR Text Key: 130784857
• Report Number: 2951238-2018-00759
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170345180
• UDI-Public: 04953170345180
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 85K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/14/2018
• 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