MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON CONTROL UNIT

Model Number	OBCU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported in the literature titled ¿impact of scope exchange from a long single balloon enteroscope to a gastroscope during enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy,¿ patients experienced adverse effects during or after procedures using olympus devices.Case with patient identifier (b)(6) reports gif-cq260.Case with patient identifier (b)(6) reports sif-q260.Case with patient identifier (b)(6) reports st-sb1.Case with patient identifier (b)(6) reports obcu.Case with patient identifier (b)(6) reports d-201-10704.Background/aims: endoscopic retrograde cholangiopancreatography (ercp) in patients with surgically altered anatomy (saa) is challenging to gastrointestinal endoscopists.The aim of this study was to evaluate the impact of scope exchange from a long single balloon enteroscope (sbe) to a gastroscope during sbe-assisted ercp (sbe-ercp) in patients with saa.Methods: patients who underwent sbe-ercp between february 2019 and october 2020 were retrospectively identified.Intubation success, scope exchange success, cannulation success, and therapeutic success were analyzed along with complications.Results: fifty-six patients with various saas underwent sbe-ercp procedures, including billroth ii subtotal gastrectomy (b-ii, n=13), pylorus-preserving pancreato-duodenectomy (pppd, n=6), roux-en-y hepaticojejunostomy (rey hj, n=4), and total gastrectomy with rey anastomosis (tg rey, n=33).Overall intubation, cannulation, and therapeutic success rates were 89.3%, 82.1%, and 82.1%, respectively.Therapeutic success rates did not differ significantly among the type of saa.Successful scope exchange rate after successful intubation was significantly higher in native papilla (b-ii and tg rey, 83.3%, 35/42) compared to bilioenteric anastomosis (pppd and rey hj, 0%, 0/8, p<0.001).Intubation success, scope exchange, and cannulation success were associated with therapeutic success (p<0.001).In multivariate analysis, successful scope exchange was the only factor related to cannulation success (p=0.02).The major complication rate was 1.8% (one perforation).Conclusions: sbe-ercp is a safe and effective procedure to treat biliary problems in patients with saa.Successful scope exchange may lead to higher therapeutic success by way of cannulation success.Adverse events occurred in six of 56 patients (10.7%).One case of perforation occurred in tg rey that required surgical repair of intestinal perforation and biliary stone removal.Asymptomatic hyperamylasemia occurred in five cases (two in b-ii, three in tg rey).There were no other complications including bleeding, post-ercp pancreatitis, or procedure-related deaths.There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction and additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: BALLOON CONTROL UNIT
• Common Device Name: BALLOON CONTROL UNIT
• 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: 14760302
• Report Number: 8010047-2022-10494
• Device Sequence Number: 16481040
• Product Code: FDA
• UDI-Device Identifier: 04953170239533
• UDI-Public: 04953170239533
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K071254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: Health Professional
• Device Model Number: OBCU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown