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

Model Number SD-7P-1

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

Patient Problems Cyst(s) (1800); 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 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 may 24, olympus medical systems corp.(omsc) received the literature "endoscopic wire-guided papillectomy versus conventional papillectomy for ampullary tumors: a prospective comparative pilot study¿.The purpose of the literature was to compare post-procedure pancreatitis rates, the success rate of pancreatic stent insertion, and complete resection rates between wire-guided endoscopic snare papillectomy (wp) and conventional esp (cp) procedures.The surgeon used a duodenoscope (olympus; tjf-260), a snare (olympus; sd-7p-1), a stent (non-olympus device) and a guidewire (non-olympus device) in the procedure.In the literature, it was reported that in wp group 1 perforation and 4 pancreatitis, 1 post-procedure bleeding occurred, while in cp group 3 pancreatitis occurred.In wp group one post-procedure bleeding and one of three pancreatitis in cp group are severe.The author wrote, ¿postpapillectomy pancreatitis occurred in four of 22 patients in the wp group and in three of 23 patients in the cp group.Pancreatitis was mild in all patients and resolved with conservative management in the wp group.Wp group showed higher number of pancreatogram cases than cp group.The mean procedure time was significantly longer in patients with pancreatitis after the procedure than in those without pancreatitis.In the cp group, three of eight patients without stents developed pancreatitis, compared with zero of 15 patients with stents.One patient without a pancreatic stent placement experienced severe pancreatitis, associated with massive peripancreatic fluid collection and a long hospitalization.Post-procedure bleeding occurred in one wp patients (severe bleeding that was managed using arterial embolization) and in two cp patients, treated with heat probe or endoscopic clipping.There were no cholangitis in both groups.One patient in the wp group experienced perforation, which improved with conservative treatment.During the follow-up period, late papillary stenosis developed in one patient in the cp group without a pancreatic stent.This was managed using an endoscopic sphincterotomy and stent placement.¿ according to the discussion, ¿inadvertent guidewire manipulation during snare papillectomy may cause pancreatitis and longer duration of guidewire placement in pancreatic duct may increase its risk.¿ based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, one severe pancreatitis in cp group might occur when the surgeon used a snare and the guidewire was moved during the procedure.This is the report regarding one severe pancreatitis associated with massive peripancreatic fluid collection and a long hospitalization.

• 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: 11944614
• MDR Text Key: 265865339
• Report Number: 8010047-2021-07133
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K955650
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD-7P-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• 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