MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; PANCREATIC DRAINAGE TUBE

Device Problem Partial Blockage (1065)

Patient Problem Abscess (1690)

Event Type  Injury  

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 Description

On july 15, 2020, olympus medical systems corp.(omsc) received literature titled "10fr s-type plastic pancreatic stents in chronic pancreatitis are effective for the treatment of pancreatic duct strictures and pancreatic stones".In the literature, it was reported that 4 stent occlusions with each one pancreatitis, one pancreatic abscess, one colon fistula, and one splenic abscess were observed in 59 chronic pancreatitis and pancreatolithiasis patients.These patients underwent 10 fr s-type pancreatic stent placement and were followed up for over 12 months.The severity of these diseases are severe.One patient presented with a pancreatic abscess, while another presented with a colon fistula, which was treated by observation.In addition, there was one case of splenic abscess, which was treated by percutaneous drainage.All three patients presented with diffuse multiple stones in the tail of the pancreatic duct.The procedure was performed using the single use pancreatic stent (pbd-234 or pbd-230).The model number was not identified.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, the literature indicated that the stent occlusions associated with the pancreatic stent.Therefore, omsc will submit 4 medical device reports (mdr) for the stent occlusions with these complications of the pancreatic drainage tube.This report is 2 of 4 reports for the stent occlusions with these complication of the pancreatic drainage tube.

• Type of Device: PANCREATIC DRAINAGE TUBE
• 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: 10372714
• MDR Text Key: 202262979
• Report Number: 8010047-2020-05325
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/06/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other