MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT 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	Bowel Perforation (2668)
Date of Event	09/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following patient identifiers are linked: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed the literature titled " complications of single-balloon enteroscopy: a nine-year multicenter experience of 2865 procedures".Literature summary: background: single-balloon enteroscopy (sbe) is an established procedure for evaluating small bowel lesions.While its efficacy is well recognized, the incidence of major complications and their associated risk factors in a large population remain unclear.Aim: to investigate the complications and risk factors associated with diagnostic sbe.Methods: this multicenter retrospective study included consecutive patients who underwent diagnostic sbe at three tertiary care hospitals between january 2016 and september 2024.Data on baseline characteristics, procedural parameters, indications, findings, and major complications were collected and analyzed.Results: a total of 2865 sbe procedures were performed in 1840 patients.The mean age was 51 ± 18 years, and 64.5% were male.The most common indication was ob ullah s et al.Complications of sbe wjg https://www.Wjgnet.Com 2 september 14, 2025 volume 31 issue 34 scure gastrointestinal bleeding (57.1%), followed by abdominal pain (30.5%).The major complication rate was 0.4% (7/1840), all of which involved acute intestinal perforation identified during the procedure.Among the perforation cases, 6 occurred in patients undergoing sbe for abdominal pain and 1 for obscure gastrointestinal bleeding.The perforation sites included the ileum (6/7) and duodenum (1/7).All cases were successfully managed surgically.Previous abdominal surgery and the use of abdominal compression were significantly associated with an increased risk of perforation (p value < 0.001 for both).In subgroup analysis, perforation rates were 2.1% (6/288) in patients with prior abdominal surgery and 1.6% (7/428) with abdominal compression.Conclusion: acute intestinal perforation is a rare but serious complication.Prior abdominal surgery and abdominal compression are important risk factors, and careful patient selection is recommended to minimize complications." type of adverse events/number of patients: event1: intestinal perforation (age73/female) event2: intestinal perforation (age58/female) event3: intestinal perforation (age67/female) event4: intestinal perforation (age20/male) event5: intestinal perforation (age53/male) event6: intestinal perforation (age55/male) event7: intestinal perforation (age24/male).The complaint is related to patient -age73/female.This patient underwent diagnostic single-balloon enteroscopy (sbe) for evaluation of abdominal pain.The procedure was performed via the oral route under general anesthesia with the application of abdominal compression.The patient's perforation site was in the duodenum measuring 5cm x 5cm.Patient underwent surgery and recovered.There was no allegation of device malfunction identified in the article.
Additional Manufacturer Narrative
Three attempts were performed to obtain additional information, but no response was received from the author.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: h6 the device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the author.

• Brand Name: SINGLE USE SPLINTING TUBE
• Common Device Name: SINGLE USE SPLINTING TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23372492
• Report Number: 3003637092-2025-00158
• Device Sequence Number: 8894383
• Product Code: FED
• UDI-Device Identifier: 04953170237201
• UDI-Public: 04953170237201
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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-Q260 ENTEROSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female