MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE PAPILLOTOMY KNIFE

Model Number	KD-211Q-0725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peritonitis (2252); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature: permanent endoscopic gallbladder stenting versus removal of gallbladder drainage,long-term outcomes after management of acute cholecystitis in high-risk surgical patients for cholecystectomy:multi-center retrospective cohort study" by a.Maruta, t.Iwashita, and keisuke iwata et al.    endoscopic transpapillary gallbladder drainage (egbd) has been reported as an effective gallbladder drainage treatment option for acute cholecystitis in high-risk surgical patients.However, the long-term outcomes such as cholecystitis' recurrence rate after placement of egb stenting (egbs) have not been well studied yet.The authors used 3 olympus devices and did not specify the adverse events in relation to the devices and therefore, the adverse events will be reported for all olympus devices (b)(6): kd-v411m-0725.(b)(6): kd-211q-0725.Complaint 3 visiglide2.1 - pancreatitis.1 - cystic duct injury, managed conservatively.3 - bile peritonitis, managed conservatively.Late adverse events (6 months and 1 year).22 - cholecystitis reoccurrence.11 -common bile duct stones.3 - common bile duct stones and reoccurrence of cholecystitis.This is report 2 of 3 for (b)(6): kd-211q-0725.
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: DISPOSABLE PAPILLOTOMY KNIFE
• Common Device Name: DISPOSABLE PAPILLOTOMY KNIFE
• 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: 13604552
• Report Number: 8010047-2022-03602
• Device Sequence Number: 11245280
• Product Code: KNS
• UDI-Device Identifier: 04953170040337
• UDI-Public: 04953170040337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950166
• 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): 05/03/2022

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: KD-211Q-0725
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 05/04/2022
• 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: Other
• Patient Sex: Unknown