MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SURGICAL SCISSORS

Model Number	FS-3L-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "surgical scissors (13b1x00277000028)", olympus selected "fs-3l-1" as a representative product.The product was unknown but a representative product was chosen for processing purposes.The device has not been returned to olympus for evaluation.The device history record was unable to be reviewed for this device since the serial and/or 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 is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Olympus reviewed the following literature titled "endoscopic internalization by cutting versus removal of the endoscopic transpapillary naso-gallbladder drainage tube in preoperative management of acute cholecystitis: a retrospective multicenter cohort study." abstract background: endoscopic transpapillary naso-gallbladder drainage (engbd)has been reported to be an effective treatment option for acute cholecystitis.At our institution, engbd was first placed for external fistula management, and endoscopic internalization by cutting was performed, shifting to endoscopic transpapillary gallbladder stenting (egbs) after improvement of cholecystitis.However, there has been no comparative study to define which preoperative management is better: converting engbd to egbs or removing engbd.The study aimed to compare the incidence rate of the late adverse events (aes) related to biliary system between shifting from engbd to egbs and removal of engbd.Methods: we retrospectively studied 122 patients who underwent engbd for acute cholecystitis between january 2010 and october 2022.The patients were divided into two groups: the cutting group (converting engbd to egbs) and the removal group (removal of engbd).The short and late clinical outcomes we recompared between groups.Results: endoscopic transpapillary naso-gallbladder drainage was successfully placed in 78.6% (96/122), and elective cholecystectomy was performed in 31 and 36 patients in the cutting and removal groups, respectively.The cumulative late-ae rates were 6.4% and 33.3% (p =.007), with a median waiting period for elective cholecystectomy of 58 and 33 days (p =.390) in the cutting and removal groups, respectively.In the multivariate analysis, only endoscopic internalization by cutting was an independent factor affecting late aes.Conclusion: endoscopic internalization by cutting engbd after the resolution of acute cholecystitis was considered effective in reducing the risk of late aes during the waiting period for an elective cholecystectomy.Type of adverse events (ae)/number of patients: pancreatitis as early aes of engbd 2 patients, bleeding as early aes of engbd 1 patient , cystic duct injury as early aes of engbd 1 patient , migration as procedure (endoscopic internalization by cutting engbd)-related adverse event 3 patients , late adverse events including recurrence of cholecystitis and cbds (common bile duct stone) 14 patients.This literature article requires 3 reports.The related patient identifiers are as follows: -(b)(6) :kd-211q-0725.-(b)(6) :fs-5l-1.-(b)(6) :fs-3l-1.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: SURGICAL SCISSORS
• Common Device Name: SURGICAL SCISSORS
• 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: 18185597
• Report Number: 9614641-2023-01759
• Device Sequence Number: 17768097
• Product Code: PTS
• UDI-Device Identifier: 04953170033377
• UDI-Public: 04953170033377
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/21/2023

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: FS-3L-1
• 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: 10/26/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown