MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CANNULA

Model Number	PR-113Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adult Respiratory Distress Syndrome (1696); Sepsis (2067); Pancreatitis (4481)
Type of Reportable Event	Serious Injury
Additional 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 and the communication with author, it was found that there was no malfunction.Review of medical safety officer.Date & location: 2021/7/14, 15:00-15:45 @teams.Attendees: (b)(6).Medical safety officer.Medical safety affairs.Product qa.Market qa.Severe pancreatitis.Severe pancreatitis was reported in this case.During ercp, olympus catheter and duodenoscope were used.The catheter was inserted into the common bile duct, but it was not reported that the catheter was inserted into the pancreatic duct.Other factors that may induce pancreatitis include stones due to cholecystitis, but the catheter might be associated with pancreatitis.On the other hand, the scope might not be associated with pancreatitis.Death.It is difficult to speculate that death would occur within 30 days after surgery due to cholangitis of the primary disease.One patient with severe pancreatitis accompanied by acute respiratory distress syndrome was described, and the association between these symptoms and death could not be denied.Based on only the information of the literature, mso could not reasonably suggest the association.Communication with author by e-mail.From: dr.(b)(6).Sent: tuesday, july 27, 2021 3:49 pm.Content: did the pep (total 26 cases) described in this article contribute to the death (3 patients of mortality)? ans: there was no patient died of the pancreatitis.They died of the pneumonia, biliary tree infection, and pancreas abscess formation with sepsis.Did the olympus catheter or duodenoscope contribute to the death (3 patients of mortality)? ans: no.Were there any malfunction of the olympus catheter or duodenoscope related to the death? ans: no.Does "one patient developed severe pep with acute respiratory distress syndrome after est in the moderate cholangitis group" include in the mortality of the moderate cholangitis group? ans: yes.The patient was a case of esrd with hemodialysis.He die of the pancreas abscess formation and severe sepsis.
Event or Problem Description
On july 5, 2021, omsc received the document "single-stage retrograde endoscopic common bile duct stone removal might be sufficient in moderate acute cholangitis with a stone size =12 mm: a retrospective cohort study with propensity score matching".The purpose of the literature was to access of single-stage endoscopic treatment for common bile duct (cbd) stone removal in patients with moderate cholangitis to determine the rates of successful stone extraction and complications.After the randomized propensity score matching, there were 90 and 134 patients in the moderate and no/mild cholangitis groups, respectively.Endoscopic retrograde cholangiopancreatography (ercp) was performed using a side view endoscope (olympus; jf-260, tjf-240) and a catheter (olympus; pr-113q).A balloon-tipped catheter and a guidewire were also used and manufactured by non-olympus.The primary outcomes were success rate of complete stone removal and rates of major complications including post-ercp pancreatitis (pep), perforation, bleeding, pneumonia, and mortality within 30 days of the procedure.Cases not requiring transfusion were defined as mild bleeding, those requiring up to four units of blood were defined as moderate bleeding, and those requiring five or more units of blood for transfusion, surgery, or angiography were defined as severe bleeding.It was reported that 12 cases with pep, 2 cases with bleeding, 4 cases with pneumonia, 2 cases with death occurred in moderate cholangitis group, while in no/mild cholangitis group 14 cases with post-ercp pancreatitis (pep), 2 cases with perforation, 2 cases with pneumonia, 1 case with death occurred.The literature wrote, ¿two patients in the moderate cholangitis group developed moderate bleeding after endoscopic sphincterotomy (est) and required endoscopic homeostasis.Additionally, one patient in the moderate cholangitis group developed severe pep with acute respiratory distress syndrome after est.Finally, one patient with end-stage renal disease in the no/mild cholangitis group developed moderate pep after extended papilla balloon dilatation, with consequent pancreatic abscess.The remaining patients with pep had mild disease and recovered with conservative therapy.¿ on (b)(6) 2021.According to the review of olympus medical safety officers, which have the medical license, 1 case with severe pep and acute respiratory distress syndrome after est in the moderate cholangitis group might be associated with using a catheter.On (b)(6) 2021.Omsc was informed by author as follow.¿there was no patient died of the pancreatitis.They died of the pneumonia, biliary tree infection, and pancreas abscess formation with sepsis.¿ the olympus catheter or duodenoscope did not contribute to the death (3 patients of mortality) and there was no malfunction of the olympus catheter or duodenoscope related to the death.¿one patient developed severe pep with acute respiratory distress syndrome after est included in the mortality of the moderate cholangitis group.The patient was a case of end stage renal disease (esrd) with hemodialysis.He died of the pancreas abscess formation and severe sepsis.¿ therefore, omsc assumes as follows.*1 case of severe pep with acute respiratory distress syndrome might be associated with a catheter.*1 case of severe pep with acute respiratory distress syndrome died of the pancreas abscess formation and severe sepsis.The death might not be almost associated with a catheter.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.This is the report regarding 1 case with severe pep and acute respiratory distress syndrome after est in the moderate cholangitis group.

• Brand Name: CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12250107
• Report Number: 8010047-2021-09527
• Device Sequence Number: 19999568
• Product Code: ODD
• UDI-Device Identifier: 04953170043840
• UDI-Public: 04953170043840
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K950729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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
• Operator of Device: No Information
• Device Model Number: PR-113Q-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other