MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL SNARE

Model Number SD-5U-1

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

Patient Problem Pancreatitis (4481)

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 serial 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 is no description of the device's malfunction.

Event Description

On sep.2, 2021, olympus medical systems corp.(omsc) received the literature titled "predictive factor of recurrence after endoscopic papillectomy for ampullary neoplasms".This study was conducted for 96 patients with ampullary neoplasms who underwent endoscopic papillectomy (ep) from january 2000 to october 2018.The median age of the patients was 69 years (range, 20-89 years), and 49 patients were men.In the literature, it was reported that the following.Bleeding, pancreatitis, cholangitis, stent migration occurred in 6, 4, 3, and 2 patients, respectively.Pancreatitis was with new or prolonged hospitalization.An endoscopic retrograde cholangiopancreatography(ercp) was performed before the ep.Ercp was performed using a duodenoscope (tjf-240 or tjf-260v).Ep was performed using a crescent electrosurgical polypectomy snare (sd-5u-1) without a prior submucosal injection.Placements of both biliary and pancreatic stents which the manufacturer was unknown were routinely attempted after ep.Based on the available information, reported bleeding, pancreantis, and cholangitis were not reported in a direct relationship with the olympus products.However, omsc assumes that the pancreatitis might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the pancreatitis might be caused or contributed to a death or serious injury.Therefore, omsc assumes that the pancreatitis was an adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the pancreatitis.

• Brand Name: ELECTROSURGICAL SNARE
• Type of Device: ELECTROSURGICAL SNARE
• 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: 12465409
• MDR Text Key: 271254338
• Report Number: 8010047-2021-11651
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD-5U-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization