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	Pulmonary Embolism (1498); Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.
Event or Problem Description
On february 1, 2021, omsc received the literature " small endoscopic sphincterotomy plus endoscopic papillary large balloon dilation for removing choledocholithiasis in patients with peripapillary diverticulum".The purpose of the literature was to assess the safety and effectiveness of small endoscopic sphincterotomy(sest) plus endoscopic papillary large balloon dilation (eplbd)for removing refractory choledocholithiasis in patients with peripapillary diverticulum.The subject patients were 137 patients with refractory choledocholithiasis stones(diameter=15 mm)concomitant with peripapillary diverticulum, treated at the first affiliated hospital of wannan medical college between november 2012 and october 2015.66 patients received sest+eplbd (group a) and the other 71 (group b), conventional endoscopic sphincterotomy (est).In the literature, it was reported that there was one case of bleeding, and eventually death due to pulmonary embolism in the group b.The author wrote, one case in the conventional est group had postoperative bleeding and eventually died due to pulmonary embolism, postoperative bleeding was considered to be related to the large magnitude of papillary sphincter incision and repeated lithotripsy, frequent access to the mesh basket, balloon, guidewire and other instruments leading to long operation time.Pulmonary embolism was considered to be probably related to the intraoperative papillary sphincter.Pulmonary embolism was considered to be probably related to the large magnitude and speed of the papillary sphincter incision during surgery, which led to a large amount of air entering the blood.The est was performed using a dual-knife (olympus; kd-211q-0725).A basket (olympus; fg22q-1) was also used during the procedure.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, the author indicated that pulmonary embolism was considered to be probably related to the intraoperative papillary sphincter.This report is regarding to one case of bleeding, and eventually death.

• 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
• MDR Report Key: 11284008
• Report Number: 8010047-2021-02264
• Device Sequence Number: 4371896
• Product Code: KNS
• UDI-Device Identifier: 04953170040337
• UDI-Public: 04953170040337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: No Information
• Device Model Number: KD-211Q-0725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death