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

Model Number KD-211Q-0725

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemostasis (1895)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc).The author has not provided additional information about individual cases.Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, we presume that the reported complications were not due to the malfunction of the device, but occurred as a general complications of the procedure.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿modified prophylactic 5-fr pancreatic duct stent enhances the rate of spontaneous dislodgement: a multicenter randomized controlled trial¿.The literature reported the result of endoscopic retrograde cholangiopancreatography (ercp) procedures and stent placement for 276 patients who deemed high risk for post-endoscopic retrograde cholangiopancreatography pancreatitis at 6 tertiary endoscopic centers between september 2015 to july 2017.The literature reported that olympus clever cut (kd-211q-0725) was used in ercp procedures.The following complications were described in the literature.Pancreatitis occurred in 18 patients.15 patients had mild pancreatitis and 3 patients had moderate pancreatitis.Additional treatments were not reported.Fever occurred in 10 patients.6 patients were treated with stent exchange or surgery, others only received antibiotics.Hemorrhage after endoscopic sphincterotomy occurred in 9 patients.1 patient required a blood transfusion, 2 patients required endoscopic hemostasis and others were unspecified.2 patients died.No further information was provided.According to the number of the type of complication and treatment, omsc is submitting 7 reports.This is the 1st report regarding of hemorrhage in 2 patient who required endoscopic hemostasis.This is 4th report of 7 reports.

• Brand Name: DISPOSABLE PAPILLOTOMY KNIFE
• Type of Device: 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: 8300673
• MDR Text Key: 134858704
• Report Number: 8010047-2019-00992
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KD-211Q-0725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention