MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE SPLINTING TUBE

Model Number	ST-SB1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "management of duodenal-jejunal polyps in children with peutz-jeghers syndrome with single-balloon enteroscopy" by barbara bizzarri, yosvaldo borrelli, nicola de¿angelis et al.This single-center prospective study was aimed to assess the efficacy and the safety of single-balloon enteroscopy (sbe) for small bowel polyps (>15 mm) in children affected with peutz-jeghers syndrome (pjs).A total of 10 10 children with pjs were included and evaluated for feasibility, technical performance, and safety.The study revealed that a total of 16 procedures had an anterograde approach, while seven had a retrograde approach, and the sbe was successful in all children without any technical problems.The study claimed that no adverse effects were reported except mild abdominal pain was reported after three procedures, and postpolypectomy perforation occurred in one patient (4.3%), requiring an emergency laparoscopy with surgical closure of the tear.The patient was discharged one week after surgery.The study concluded sbe is an effective and endoscopic tool for treating small bowel polyps in children with pjs.Furthermore, large multicenter studies are warranted to accurately determine the safety of therapeutic sbe in children.The authors reported using two different olympus devices and the following adverse events: in patient (no.5) a postpolypectomy perforation occurred (4.3%), requiring an emergency laparoscopy with surgical closure of the tear.The patient was discharged 1 week after surgery, and no other complications were observed during or after the admission.This article includes 2 reports: patient identifier (b)(6): sif-q180.Patient identifier (b)(6): st-sb1.This is report 2 of 2 for patient identifier (b)(6).
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Additional information received from the author: the serial number is not available.The perforation was secondary to a particular implant base of the polyp and the small size of the child.Physician ruled out a technical problem with the olympus instrumentation.
Additional Manufacturer Narrative
This supplemental report is being sent to provide additional information from the author.
Additional Manufacturer Narrative
This report is being supplemented to provide 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: SINGLE USE SPLINTING TUBE
• Common Device Name: SINGLE USE SPLINTING TUBE
• 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: 13690423
• Report Number: 8010047-2022-04051
• Device Sequence Number: 14730321
• Product Code: FED
• UDI-Device Identifier: 04953170237201
• UDI-Public: 04953170237201
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 05/13/2022

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: ST-SB1
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 04/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/13/2022; 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIF-Q180.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 44 KG