MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XP190N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Type  Injury  

Event Description

It is reported in the literature titled ¿combined endoscopic-percutaneous treatment of upper gastrointestinal enterocutaneous fistula using vacuum therapy and resorbable plug insertion (vac-plug)", patients five experienced serious adverse events after procedures using an evis exera iii gastrointestinal videoscope.Case with patient identifier (b)(6) reports patient one of five (b)(6).Case with patient identifier (b)(6) reports patient two of five (b)(6).Case with patient identifier (b)(6) reports patient three of five (b)(6).Case with patient identifier (b)(6) reports patient four of five (b)(6).Case with patient identifier (b)(6) reports patient five of five (unknown patient).After gastrointestinal resections, leakages can occur, persist despite conventional therapy and result in enterocutaneous fistulae.We developed a combination method using flexible endoscopic techniques to seal the enteric orifice with an absorbable plug in addition to a percutaneously and fistuloscopically guided open-pore film drainage (vac-plug method).We retrospectively searched our endoscopy database to identify patients treated with the outlined technique.The clinical and pathological data were assessed, the method analyzed and characterized, and the technical and clinical success determined.We identified 14 patients that were treated with the vac-plug method (4 females, 10 males with a mean age of 56 years, range 50¿74).The patients were treated over a time period of 23 days (range 4¿119) in between one to thirteen interventions (mean n= 5).One patient had to be excluded due to short follow-up after successful closure.Seventy-seven percent (10/13) were successfully treated with a median follow-up of 453 days (range 35¿1246) thereafter.No treatment related complications occurred during the therapy.The data of the analysis showed that the vac-plug therapy is safe and successful in a relevant proportion of the patients.It is easy to learn and to apply and is well tolerated.In our opinion, it is a promising addition to the armamentarium of interventional methods of these difficult to treat patients.Of course, its usefulness must be further validated in larger prospective studies.Nine patients were treated successfully, and the fistulas closed without any further clinically relevant findings, and we had a sufficient follow-up for a healing process (453 days (range 35¿1246)).In one patient (no.6), the fistula was technically successful treated, but due to a long-lasting esophageal fistula and systemic tumor recurrence, she died of pneumonia 10 days after the end of the therapy; therefore, the therapeutic success could not be fully evaluated.One patient (no.7) did not show any significant healing progress.The infection was maintained by an intra-thoracic non resorbable mesh and a modified peg was inserted to ensure proper drainage.The patient died nine days later following acute septic portal vein thrombosis.In two patients (no.11 and 12) the fistula persisted resulting in recurrent septic complications (open abdomen and huge leakage of 3 cm in diameter) so that surgical revision was performed.However, in both cases another leakage recurred, and the patients died due to septic complications.Of note, one clinically relevant esophageal stenosis and a duodenal stenosis were detected in the late course requiring surgical and endoscopic intervention.Tus, success rate with adequate follow-up was 10/13 cases (77%).There is no report of any olympus device malfunction in any procedure described in this literature.Additional information has been requested from the author, at this time, no additional information has been provided.

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.

Manufacturer Narrative

This report is being updated to provide additional information reproted by the authoring physician.New information is reported in b5.

Event Description

Update: additional information provided by the authoring physician: no olympus device malfunctioned during any procedure described in this literature (study).No olympus device caused or contributed to any patient death during this study.No olympus device caused or contributed to any of the adverse effects experienced by patients in this study.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15248533
• MDR Text Key: 298118965
• Report Number: 9610595-2022-01037
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305313
• UDI-Public: 04953170305313
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-XP190N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female