MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 03/01/2021

Event Type  Injury  

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 Description

Olympus reviewed the following literature titled "endoscopic closure of an acute duodenal perforation occurring during endoscopic ultrasound using endoclips and polyglycolic acid sheets with fibrin glue".This case report discussed about acute duodenal perforation during endoscopic ultrasound (eus).During exploration for a puncture route from the duodenal bulb using a linear echoendoscope under carbon dioxide insufflation, the duodenal lumen was suddenly filled with blood.A perforation <15 mm was identified and attempted an endoscopic closure with multiple endoclips.Strips of bioabsorbable polyglycolic acid (pga) sheets were placed over the gaps between the endoclips with biopsy forceps and fixed in place with fibrin glue, completely covering the perforation site.This case report concludes that, the surgery was avoided due to successful endoscopic treatment using endoclips and pga sheets with fibrin glue without otsc.This method may be useful for repairing acute duodenal perforations during eus and should therefore be known to pancreatobiliary endoscopists.Type of adverse events: perforation (with bleeding) 1 patient.Mild fever after the procedure 1 patient.There is no report of any olympus device malfunction in any procedure described in this study.

Event Description

The following additional information was received from the author: an olympus device did not cause or contribute to any of the adverse events described in the article.In addition, it was confirmed that an olympus device did not malfunction during any of the procedures.

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 event 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.This supplemental report includes a correction to d8, e4 and g2.Information added that was inadvertently not included on previous submissions.Also, information added to b5 to include new information received from the author.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16165291
• MDR Text Key: 307466629
• Report Number: 3002808148-2023-00436
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• 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): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female