MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE PRELOADED SPHINCTEROTOME

Model Number	KD-VC412Q-0215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	11/26/2019
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.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant.
Event or Problem Description
It is reported in the literature titled does the use of low osmolality contrast medium reduce the frequency of post-endoscopic retrograde cholangiopancreatography pancreatitis: a comparative study between use of low and high osmolality contrast media,¿ patients experienced adverse events after endoscopic retrograde cholangiopancreatography (ercp) procedures using olympus devices.Case with patient identifier (b)(6) reports pr-4q-1.Case with patient identifier (b)(6) reports kd-vc412q-0215.Case with patient identifier (b)(6) reports fg-v435p.Case with patient identifier (b)(6) reports jf-260v.Study aim: evaluate the useful ness of iodixanol for prevention pep in comparison with meglumine amidotrizoate.Method: two hundred and ninety-one patients were enrolled and divided into the 2 groups according to the contrast medium used.One hundred and fifty-five patients underwent ercp with meglumine amidotrizoate, and 136 patients underwent ercp with iodixanol.The primary outcome of this study was the incidence of pep associated with the use of each contrast medium.Results: in this study, comparison of the meglumine amidotrizoate treatment and iodixanol treatment groups showed no significant difference with respect to the incidence of pep.In addition, there was also no difference between the groups with respect to pep severity.Conclusion: this study suggested that iodixanol does not necessarily contribute to the prevention of pep in comparison with meglumine amidotrizoate.Across both study groups patients experienced post-ercp pancreatitis (pep) ranging from mild to moderate severity (there were no cases of severe pep), and post ercp hyperamylasemia.The literature does not report what treatment was required.There is no report of olympus device malfunction described in this study.
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 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 was no complaint reported on the subject device.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.

• Brand Name: SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• 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: 14102113
• Report Number: 8010047-2022-06192
• Device Sequence Number: 17749294
• Product Code: KNS
• UDI-Device Identifier: 04953170399336
• UDI-Public: 4953170399336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160241
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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-VC412Q-0215
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 08/16/2022
• 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