MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

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

Patient Problems Unspecified Infection (1930); Pancreatitis (4481); Unspecified Gastrointestinal Problem (4491)

Event Date 12/07/2020

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

Olympus medical systems corp.(omsc) received a literature titled "pancreatic ascites and pleural effusion in children: clinical profile, management and outcomes".The literature reported the result of 214 children patients with chronic pancreatitis (cp) who underwent endoscopic retrograde cholangiopancreatography (ercp) and transpapillary stenting procedure using the olympus tjf-q180v and unspecified stent from march 2016 to march 2020.The children patients had chronic pancreatitis with pancreatic ascites and pleural effusion.In the literature, it was reported complication as follows; post endotherapy infection (3 cases) : requiring intravenous antibiotics.Ruptured pseudocyst (1 case) : requiring surgery.Chronic idiopathic pancreatitis (13 cases).Exocrine pancreatic insufficiency (1 case).There are not mentioned that these complications were related to the subject device in question.In addition, "ruptured pseudocyst" has occurred in patients who have not underwent ercp using the subject device.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.However, omsc assumes that "post endotherapy infection" might be related to the subject device, and the subject device was might be caused or contributed to a death or serious injury.Therefore, omsc determined that the "post endotherapy infection" was adverse events to submit.Omsc will submit 3 medical device reports (mdrs) depending on the event.This report is the second of three.

Manufacturer Narrative

This report is being supplemented to provide corrections as information added to these fields were inadvertently not included on the initial medwatch.Correction to a1, b3, b5, d4, d5, d8, e1, e2, e3, e4, g2 and h6.Olympus will continue to monitor field performance for this device.

Event Description

Background: pancreatic ascites (pa) and pleural effusion (ppe) are rarely encountered in children.They develop due to disruption of the pancreatic duct (pd) or leakage from an associated pancreatic fluid collection (pfc).The literature on childhood pa/ppe and its management is scarce.Methods: a retrospective review of children with pa/ppe diagnosed and managed at our center over the last 4 years was performed.The clinical, biochemical, radiological and management profiles were analyzed.Conservative management included nil per oral, octreotide and drainage using either percutaneous catheter or repeated paracentesis.Endotherapy included endoscopic retrograde cholangiopancreatography (ercp) and transpapillary stenting.Results: of the 214 children with pancreatitis, 15 (7%) had pa/ppe.Median age was 9 years with a third under 2 years.Median ascitic fluid amylase was 8840 u/l and all had elevated protein (>2.5 g/dl) and low serum ascites-albumin gradient ascites (<1.1).While pa/ppe was the first manifestation of underlying chronic pancreatitis (cp) in 10 children (67%), trauma was seen in 4 (26%) and hypertriglyceridemia in 1 (7%).On imaging, pd disruption could be identified in 10 (67%) children.Ercp and stenting was done in 10 children.Conservative management alone (n ¼ 4) and endotherapy (n ¼ 10) was successful in 93% with only one requiring surgery.The younger children (n ¼ 4), were managed conservatively and only 1 of them required surgery.Resolution of pa/ppe was achieved in all with no recurrences.Conclusions: conservative management and ercp plus transpapillary stenting results in resolution of majority of pediatric pa/ppe.Children presenting with pa/ppe needs to be evaluated for cp.Related reports: patient identifier (b)(6), patient identifier (b)(6), patient identifier (b)(6).This medwatch report is for patient identifier (b)(6).

Manufacturer Narrative

This report is being submitted, to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12431025
• MDR Text Key: 270498886
• Report Number: 8010047-2021-11330
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 02/08/2023; 05/07/2024
• Supplement Dates FDA Received: 02/21/2023; 05/07/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention