MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; SMALL INTESTINAL VIDEOSCOPE

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

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

On december 2, olympus medical systems corp.(omsc) received the literature "review status of single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy: systematic review and meta-analysis on biliary interventions.The purpose of the literature was to evaluate the efficacy of single-balloon enteroscope (sbe)-assisted endoscopic retrograde colangiopancreatography (ercp) in patients with surgically altered anatomy and elucidate the current status.The procedure was performed using a single-balloon enteroscope.The model was unknown.In the literature, it was reported 24 pancreatitis, 6 cholangitis, 3 bleedings, and 6 perforations.Two pancreatitis of 24 and one perforation of 6 were severe.The literature wrote, of the 74 cases of adverse events, three cases with roux-en-y gastrectomy were severe (two severe pancreatitis cases and one perforation case).Unfortunately, one of the patients with severe pancreatitis eventually died.Of the six cases of perforation observed, four occurred during scope insertion, whereas two occurred during either endoscopic sphincterotomy or the precut technique.Of these, five cases could be treated through conservative treatment without surgery, whereas surgical intervention was required in one case presenting roux-en-y gastric bypass.Based on the available information, no malfunction was reported and a direct relationship between the olympus product and these complications could not be determined.Omsc decided that any complications tended to occur because the subject patient was anatomically changed.However, 2 cases of severe pancreatitis and 1 case of severe perforation might be serious injury, and the olympus single-balloon enteroscope might be used when these complications occurred.This is the report regarding 1 case of severe perforation.

Manufacturer Narrative

The subject device was not returned to olympus.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.

Manufacturer Narrative

The subject device was not returned to olympus.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 december 2, olympus medical systems corp.(omsc) received the literature "review status of single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy: systematic review and meta-analysis on biliary interventions.The purpose of the literature was to evaluate the efficacy of single-balloon enteroscope (sbe)-assisted endoscopic retrograde colangiopancreatography (ercp) in patients with surgically altered anatomy and elucidate the current status.The procedure was performed using a single-balloon enteroscope.The model was unknown.In the literature, it was reported 24 pancreatitis, 6 cholangitis, 3 bleedings, and 6 perforations.Two pancreatitis of 24 and one perforation of 6 were severe.The literature wrote, of the 74 cases of adverse events, three cases with roux-en-y gastrectomy were severe (two severe pancreatitis cases and one perforation case).Unfortunately, one of the patients with severe pancreatitis eventually died.Of the six cases of perforation observed, four occurred during scope insertion, whereas two occurred during either endoscopic sphincterotomy or the precut technique.Of these, five cases could be treated through conservative treatment without surgery, whereas surgical intervention was required in one case presenting roux-en-y gastric bypass.Based on the available information, no malfunction was reported and a direct relationship between the olympus product and these complications could not be determined.Omsc decided that any complications tended to occur because the subject patient was anatomically changed.However, 2 cases of severe pancreatitis and 1 case of severe perforation might be serious injury, and the olympus single-balloon enteroscope might be used when these complications occurred.This is the report regarding 1 case of severe perforation.

• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• 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: 13049304
• MDR Text Key: 285239709
• Report Number: 8010047-2021-16463
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2021
• 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): Required Intervention; Other