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	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature article: "water exchange-assisted vs.Carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial" by shuhui liang, et al.  abstract: background single-balloon enteroscopy (sbe) is a valuable but difficult modality for the diagnosis and treatment of small-bowel disease.The water exchange method has the advantage of facilitating intubation during colonoscopy.Here, we evaluated the effects of water exchange on procedure-related variables related to sbe.Methods this randomized controlled trial was conducted in a tertiary-care referral center in (b)(6).Patients due for attempted total enteroscopy were randomly allocated to undergo water exchange-assisted (water exchange group) or carbon dioxide-insufflated enteroscopy (co2 group).All patients were planned to undergo both anterograde and retrograde procedures.The primary outcome was the total enteroscopy rate.Secondary outcomes included the maximal insertion depth, positive findings, procedural time, and adverse events.Results: in total, 110 patients were enrolled, with 55 in each group.Baseline characteristics between the two groups were comparable.Total enteroscopy was achieved in 58.2 % (32/55) of the water exchange group and 36.4 % (20/55) of the control group (p = 0.02).The mean (standard deviation) estimated intubation depth was 521.2 (101.4) cm in the water exchange group and 481.6 (95.2) cm in the co2 group (p = 0.04).The insertion time was prolonged in the water exchange group compared with the co2 group (178.9 [45.1] minutes vs.154.2 [27.6] minutes; p < 0.001).Endoscopic findings and adverse events were comparable between the two groups.Conclusions: the water exchange method improved the total enteroscopy rate and increased the intubation depth during sbe.The use of water exchange did not increase the complications of enteroscopy.The authors used the following olympus devices: patient identifier (b)(6): sif-q260.Patient identifier (b)(6): st-sb1.Patient identifier (b)(6): ofp (& maj-1606).Patient identifier (b)(6): obcu, balloon control unit.Adverse events reported: post-procedure bleeding: 1 from co2 group: one patient in the co2 group who had a gist and underwent biopsy experienced post-procedural bleeding.The patient later underwent surgical management.Cardiac mucosal laceration 1 from water exchange group: intubation ceased in one patient in the water exchange group because of cardiac mucosal laceration, which was successfully treated by conservative therapy.This is report 4 of 4 for patient identifier (b)(6): obcu, balloon control unit (bleeding only).
Event or Problem Description
Additional information was provided by the author: in the opinion of the author the adverse events were not attributed to the olympus device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• 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: 14014189
• Report Number: 8010047-2022-05682
• Device Sequence Number: 12337579
• Product Code: FDA
• UDI-Device Identifier: 04953170239533
• UDI-Public: 04953170239533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SIF-Q260, SN:(B)(6).; SIF-Q260.; ST-SB1.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown