Model Number TJF-260V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pancreatitis (4481)
|
Event Date 10/24/2017 |
Event Type
Injury
|
Event Description
|
Olympus reviewed the following literature: olympus medical systems corp.(omsc) received a "tips for using spyglass peroral pancreatoscopy and x-ray-guided electrohydraulic lithotripsy for refractory pancreatic stones".This retrospective study was aimed to evaluate the efficacy of peroral pancreatoscopy (pops) and x-ray-guided electrohydraulic lithotripsy (ehl) in treating refractory pancreatic stones.A total of 159 patients with symptomatic chronic pancreatitis and pancreatic stones were treated with combined extracorporeal shock wave lithotripsy (eswl) and/or endoscopic stone lithotomy/endoscopic lithotripsy (el).Of them, 141 cases were successfully completed stone lithotripsy, but 18 patients (refractory cases) had undergone ehl procedures as the second treatment modality.Pops-guided ehl was performed in nine cases, and x-ray-guided ehl was performed in nine cases.The study reported that stone fragmentation was successful in nine (50%) patients: four (4/9) in the pops-guided ehl group and five (5/9) in the x-ray-guided ehl group.Two patients developed mild post-ercp pancreatitis following x-ray-guided ehl.The study concluded that pops and x-ray-guided ehl might be an alternative treatment for refractory stones.But, as ehl can cause severe complications, adequate precautions are necessary for these treatments.This article includes 2 reports: patient identifier (b)(6) for tjf260v.Patient identifier (b)(6) for tjf-240.This is report 2 of 2 for patient identifier (b)(6) for tjf260v for the following adverse event: the authors reported 2 patients with moderate post-ercp pancreatitis (pep); treatment was conservative management.
|
|
Manufacturer Narrative
|
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
|
|
Event Description
|
Additional information received from author: in the author's medical opinion, the olympus device did not cause the adverse event.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information received from the author.New information added to event.
|
|
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.
|
|
Search Alerts/Recalls
|