MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. CLIP

Model Number	HX-610-135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "ez clip", olympus selected "hx-610-135" as a representative product.This device has not been returned for evaluation.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "ps-10 evaluation of the usefulness of prophylactic clipping with sureclip for wound bleeding after endoscopic papillectomy".Complications including postoperative wound bleeding are frequently observed in endoscopic papillectomy (ep).We have long used a clip to suture the wound to prevent wound bleeding.Recently, we have been using the sure clip (micro-tech), which is easy to operate even with a duodenoscope.The purpose of this study was to evaluate the efficacy of sure clip placement for post-ep wound bleeding.Type of adverse event/number of patients: bleeding - 39.2%; pancreatitis - 8.7%; cholangitis - 0.5%; perforation - 3.3%.

• Brand Name: CLIP
• Common Device Name: CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17188024
• Report Number: 9614641-2023-00894
• Device Sequence Number: 12615851
• Product Code: PKL
• UDI-Device Identifier: 04953170200311
• UDI-Public: 04953170200311
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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-610-135
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 05/24/2023
• Initial Report FDA Received Date: 06/22/2023
• 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: Other
• Patient Sex: Unknown