MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LONG CLIP

Model Number	HX-610-090L
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	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported in the literature article titled ¿prophylactic clip closure for mucosal defects is associated with reduced adverse events after colorectal endoscopic submucosal dissection: a propensity-score matching analysis¿ patients experienced perforation and/or bleeding events during or after procedures using olympus devices.Case with patient identifier (b)(6) reports kd-655q.Case with patient identifier (b)(6) reports hx-610-090l.Case with patient identifier (b)(6) reports hx-202ur.Case with patient identifier (b)(6) reports pcf-h290z1.Case with patient identifier (b)(6) reports pcf-q260ai.Study background and aim it is unclear whether prophylactic endoscopic closure after colorectal endoscopic submucosal dissection (esd) reduces the risk of postoperative adverse events due to variability in lesion characteristics.Therefore, we conducted a retrospective study using propensity score matching to evaluate the efficacy of prophylactic clip closure in preventing postoperative adverse events after colorectal esd.Methods: this single-center retrospective cohort study included 219 colorectal neoplasms which were removed by esd.The patients were allocated into the closure and non-closure groups, which were compared before and after propensity-score matching.Post-esd adverse events including major and minor bleeding and delayed perforation were compared between the two groups.Results: in this present study, 97 and 122 lesions were allocated to the closure and non-closure groups, respectively, and propensity score matching created 61 matched pairs.The rate of adverse events was significantly lower in the closure group than in the non-closure group (8% vs.28%, p=0.008).Delayed perforation occurred in two patients in the non-closure group, whereas no patient in the closure group developed delayed perforation.In contrast, there were no significant differences in other postoperative events including the rate of abdominal pain; fever, white blood cell count, and c-reactive protein; and appetite loss between the two groups.Conclusions: propensity score matching analysis demonstrated that prophylactic closure was associated with a significantly reduced rate of adverse events after colorectal esd.When technically feasible, mucosal defect closure after colorectal esd may result in a favorable postoperative course.The total number of adverse events after colorectal esd, including delayed perforation and post-esd bleeding, was significantly higher in the non-closure group than in the closure group (28% vs.6%, p < 0.001).Similarly, the proportion of patients with fever was significantly higher in the non-closure group than in the closure group (12% vs.2%, p=0.019).However, there were no significant differences in the proportion of patients with abdominal pain, wbc count, c-reactive protein levels, and appetite loss between the two groups.There is no report of any olympus device malfunction reported in any procedure described in this literature.
Event or Problem Description
New information reported by the author/physician: there was no malfunction of any olympus devices during the procedures described in this literature.I do not believe that an olympus device or product specifications are related to the adverse events that occurred.
Additional Manufacturer Narrative
This report is being submitted to report the investigation findings and additional information reported by the author/physician.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.It is not possible to conclusively identify the root cause of the reported event.Based on the investigation finding and additional information provided by the author/physician it is likely the event is a complication associated with the surgical procedure.The event occurred after the doctor considered the clinical risk of the surgical procedure.In addition, the author/physician confirmed there was no olympus device malfunction.

• Brand Name: LONG CLIP
• Common Device Name: LONG 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: 14604972
• Report Number: 8010047-2022-09503
• Device Sequence Number: 5041742
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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-610-090L
• 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: 05/08/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/06/2022
• 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; Other
• Patient Sex: Unknown