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

Model Number	HX-202LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "treatment results of endoscopic mucosal resection with a ligation device for duodenal neuroendocrine tumors".Literature summary: this study examined the treatment results of endoscopic mucosal resection with a ligation device (emr-l) for the removal of duodenal nets located in the submucosal layer without metastasis.Emr-l can be performed with less technical skill, and the ligation device reduces the rate of positive vertical margin.The en bloc resection rate and endoscopic complete resection rate were both (b)(4).Complete resection was achieved pathologically in 7 lesions ((b)(4)).The vertical margins were negative in all cases.Lymphatic vessel invasion was observed in three patients, all of whom underwent additional surgery with lymph node dissection (one of them also exhibited blood vessel invasion and a positive horizontal margin).No evidence of residual tumors or lymph node metastasis was observed in any of the patients.No recurrence was observed in any of the 10 patients (mean follow-up period: 18.6 months).One patient (10.0%) experienced intraoperative bleeding.Perforation occurred in 1 patient (10.0%), but the condition was managed well by conservative therapy.Emr-l was an acceptable method for endoscopically resecting submucosal duodenal nets, and the nets resected by emr-l were tumor-negative in the vertical margins mucosal defects remaining after emr-l were closed using conventional hemoclips (ez clip) to prevent any delayed bleeding or perforation.The authors did not specify which devices caused or contributed to the intraprocedural bleeding and perforation.Therefore, the olympus hemoclips will be reported.Type of adverse events/number of patients: intraprocedure bleeding - (1), perforation - (1).This article includes 5 reports as follows: patient identifier (b)(4) for gif-q260j, patient identifier (b)(4) for nm-610l-0423, patient identifier (b)(4) for sd-210l-10, patient identifier (b)(4) for um-s20-20r, patient identifier (b)(4) for hx-202lr.This report is 5 of 5 for patient identifier (b)(4) for hx-202lr.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• 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 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: 14346458
• Report Number: 8010047-2022-07970
• Device Sequence Number: 12061577
• Product Code: PKL
• UDI-Device Identifier: 04953170385926
• UDI-Public: 04953170385926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2022

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-202LR
• 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: 04/10/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SERIAL/LOT NUMBERS: (B)(4); UNKNOWN SERIAL/LOT NUMBERS:(B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown