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

Model Number	HX-202UR
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clip eventually detached and remained in the patient as originally intended.The rest of the clip device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.As a preventive measure, the instruction manual states that to avoid patient injury and clip non-detachment, ¿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.¿ and ¿do not try to forcibly remove the clip if it becomes caught on the distal end of the coil sheath.Forcible removal of the clip could cause patient injury such as perforation, bleeding, or mucous membrane damage.¿ the instruction manual has directions for emergency removal of the device when the clip does not detach.Furthermore, the instruction manual also contains preventive warnings and cautions regarding bleeding: ¿¿clip performance for hemostatis is limited.Prepare more than one hemostatic device and select appropriate hemostatic device or use it together to respond to different hemorrhage situations¿ and ¿use this instrument in an environment equipped to accommodate open surgery.¿.
Event or Problem Description
Olympus was informed that towards the end of a colonoscopy procedure, the clip was closed onto a polyp within the sigmoid colon tissue, but the clinician could not immediately detach the clip from the rest of the clip device.The clip eventually was detached after a procedure delay of 13 to 15 minutes.The patient had no reported additional bleeding or injury.Both the clip device and the olympus pcf-q180 endoscope used with the clip had been inspected prior to use, with no anomalies found.
Additional Manufacturer Narrative
The referenced device was returned and forwarded to the original equipment manufacture for investigation.Only one piece was returned.The investigation noted that the clip had detached from the distal portion and was not returned.A visual inspection was performed and found the hook was broken off and the limiter in the control section of the clipping device was not broken off.The cause of the clip releasing failure could not be conclusively determined because the failure did not reappear.Based on the investigation findings the hook may have broken off due to an excessive force applied to the hook after releasing the clip.  additionally, the device history records were reviewed for this lot and the review revealed the lot had passed all the event-related inspection items.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8215602
• Report Number: 2951238-2019-00323
• Device Sequence Number: 19230647
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 86K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS PCF-Q180 ENDOSCOPE
• Patient Age: 51 YR
• Patient Weight: 108