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

Model Number	HX-110QR
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device together with the clip was returned to olympus medical systems corp.(omsc) for evaluation.The clip had no abnormalities related to the failure of releasing.The coil sheath of the insertion portion of the subject device was buckled (bent) at two points.The coil sheath had no other abnormalities.When the slider was operated, it did not move smoothly.The operation wire was bent around the hook.When the operation of clipping was checked by combining the subject device with a new clip, the clip could be released after clipping.The failure of releasing was not reproduced.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 due to such as the bent of the coil sheath and the slider could not be pulled out all the way to the end.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.Do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding, or mucous membrane damage.
Event or Problem Description
We received the following report.During a procedure, the subject device (clip fixing device) was used for hemostasis.The clip used in combination with the subject device could not be released after clipping patient's tissue.The user tried to remove the subject device from the patient.The subject device was removed from the clip.The intended hemostasis could not be performed.No further information was provided.On oct 31, 2019, the following information was provided.The subject device was removed together with the clip that grabbed the tissue.As a result, the patient bled.The intended procedure was completed with another clip in combination with the subject device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9302838
• Report Number: 8010047-2019-03912
• Device Sequence Number: 2104932
• Product Code: PKL
• UDI-Device Identifier: 04953170200205
• UDI-Public: 04953170200205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: HX-110QR
• Device Lot Number: 84K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other