MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CLIP

Model Number	HX-610-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that the user facility as follows, patient was suspected of having ulcerative colitis, a colon examination was performed on (b)(6) 2021.A polyp was found, and after endoscopic mucosal resection(emr), a hemostatic clip (subject device) was used.Two days after the procedure, symptoms of itching and blisters developed in the mouth and anus of patient.Topical steroids were applied to the mouth, and the symptoms are now recovering.However, blisters-like symptoms also appear on the fingertips.The patient also has a history of metal allergies.The degree of allergy is unknown because no allergy test has been performed.
Additional Manufacturer Narrative
The subject device has not been returned to omsc.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Additional Manufacturer Narrative
Correction to g2 to add the foreign country japan.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the production lot number and manufacturing date were unknown, the following device history record (dhr) for one year (november 2020 to october 2021) from the date of receipt of the report were confirmed, and the inspection items related to the indicated event were reviewed.There was no abnormality.Because the device was not returned and based on the results of the investigation, a root cause could not be determined.However, it is likely the failure was not due to an abnormality in the device since the patient has a known history of metal allergies, the clip uses a biocompatible material, and there is no abnormality in dhr.The following is included in the device instructions for use (ifu): "as the clips are made of stainless steel, do not use them on a patient who is severely allergic to metals.Otherwise, allergic symptoms may occur." olympus will continue to monitor field performance for this device.

• Brand Name: CLIP
• Common Device Name: 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: 12809604
• Report Number: 8010047-2021-14541
• Device Sequence Number: 17332633
• Product Code: PKL
• UDI-Device Identifier: 04953170415111
• UDI-Public: 04953170415111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: HX-610-090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female