MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISTAL ATTACHMENT

Model Number	MH-588
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-0000312.
Event or Problem Description
Olympus reviewed the article "quantification of interstitial cells of cajal and fibrosis during gastric per-oral endoscopic myotomy and its association with clinical outcomes." this was a prospective study of gastroparetic patients who underwent g-poem and intraprocedural pyloric muscle biopsies between (b)(6) 2022 and (b)(6) 2023.Type of adverse events/number of patients.Mucosotomy: 1 patient.This was adequately closed on the mucosal side with placement of two hemostatic clips.
Event or Problem Description
Objective: alterations to interstitial cells of cajal (icc) and collagen fibrosis have been implicated in the pathogenesis of gastroparesis.We aimed to evaluate the feasibility and safety of pyloric muscle sampling during gastric peroral endoscopic myotomy (g-poem) and the association between pyloric icc density and degree of fibrosis with clinical outcomes.Patients and methods: this was a single-center prospective study.Icc count was estimated using cd117 stain and trichome for collagen fibrosis.Clinical response to g-poem was defined as an improvement of = 1 point on the gastroparesis cardinal symptom index.Results: fifty-six patients (median age 60 years, 71.4% women) underwent g-poem (100% technical success; 71.4% clinical response).Icc depletion (< 10/high-power field) and fibrosis were encountered in 70.4% and 75% of the cases, respectively.There was no difference in mean icc count between g-poem responders vs.Non-responders (7±3.6 vs.7.7±3.3; p = 0.9).There was no association between icc density or degree of fibrosis with the etiology of gastroparesis, duration of symptoms, gastric emptying rate, or pyloric impedance planimetry.Patients who did not respond to g-poem had a significantly higher degree of moderate/severe fibrosis when compared with those who responded (81.3% vs.25%; p = 0.0002).Conclusions: pyloric muscle biopsies during g-poem was feasible and safe.Icc depletion and pyloric muscle fibrosis are common in gastroparetic patients.The degree of fibrosis may be related to pyloric dysfunction and clinical response to g-poem.Additional studies are needed to confirm these results.Reported adverse event: there was one ae (1.8%).In that patient, a mucosotomy was identified after completion of the pyloromyotomy.This was adequately closed on the mucosal side with placement of two hemostatic clips.
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 serial and/or 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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: DISTAL ATTACHMENT
• Common Device Name: DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19606373
• Report Number: 9614641-2024-01322
• Device Sequence Number: 8084285
• Product Code: FDS
• UDI-Device Identifier: 04953170047879
• UDI-Public: 04953170047879
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: MH-588
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EVIS EXERA GASTROINTESTINAL VIDEOSCOPE, GIF-H190.; SINGLE USE ELECTROSURGICAL KNIFE, KD-611L.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown