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 Code	Unspecified Respiratory Problem (4464)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature article, "endoscopic submucosal dissection and tunneling procedures using a novel all-in-one bipolar device" by zaheer nabi, et al.    this retrospective study was aimed to evaluate the use of a new multifunctional bipolar device to perform per-oral endoscopic myotomy (poem), submucosal tunneling endoscopic resection (ster), and endoscopic submucosal dissection (esd).A total of 10 patients had undergone the procedures included poem (n = 7), ster for esophageal sub-epithelial tumor (n = 1), esd for rectal polyp (n = 1), and gastric neuroendocrine tumor (n = 1).The study reported that poem was completed in all patients and the patients who underwent ster and esd, en-bloc resection was achieved in all.There were no reported major adverse events except a few mild to moderate adverse events.The study concluded that the use of the new bipolar device for esd was feasible and safe.However, the feasibility and safety of the novel bipolar device for these procedures should be explored further in studies with a larger sample size.The authors reported using 2 different olympus devices (gif-1th190 and ez clip, hx610 ¿ 090l) in their procedures and reported the adverse events for specific patients: case 1: retroperitoneal co2; case 3: capno-peritoneum; case 8: empyema.This article includes 6 reports as follows: (b)(6) - case 1: gif-1th190; (b)(6) - case 1: hx-610¿090l; (b)(6) - case 3: gif-1th190; (b)(6) - case 3: hx-610-090l; (b)(6) - case 8: gif-1th190; (b)(6) - case 8: hx-610¿090l.This report is 4 of 6 for (b)(6) - case 3: hx-610-090l.The patient with capnoperitoneum required needle drainage and the patient with retroperitoneal co2 accumulation required temporary cessation of the procedure.
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.
Event or Problem Description
Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events.The author stated the adverse events/complications were inherent to the procedure itself.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from the author.

• 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: 13839721
• Report Number: 8010047-2022-04741
• Device Sequence Number: 19080384
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 09/01/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 05/12/2022; 09/23/2022
• 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 Age: 52 YR
• Patient Sex: Male