MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled effectiveness of early endoscopic ultrasound guided drainage for postoperative fluid collection¿ two patient experienced bleeding events during procedures using olympus devices.Study background and aim: postoperative abdominal fluid collections (pafcs) are a potentially fatal complication of pancreatobiliary surgery.Endoscopic ultrasound (eus)-guided drainage has recently been shown to be effective in treating pafcs of more than 4 weeks old.Little is currently known, however, regarding the eus-guided drainage of pafcs of less than 4 weeks.This study assessed the efficacy and safety of the early drainage methods: retrospective data analysis of patients who had undergone eus-guided pafc drainage between july 2008 and january 2018 were retrospectively analyzed.Data of eus-guided pafc drainage were obtained from prospectively collected eus database of our institute and reviewed of patients¿ clinical parameters based on electrical medical record.Results: a total of 48 patients who had undergone eus-guided pafc drainage within 4 weeks of pancreatobiliary surgery were enrolled.The indications of procedure included abdominal pain (n=27), fever (n=18), leukocytosis (n=2), and increased size of pafc during external tube drainage (n=1).Technical success was achieved in all cases, and the clinical success rate was 95.8% (46/48).Four patients underwent secondary procedures.The median period from surgery to eus-guide drainage was 14 days (interquartile range [iqr] 10¿16), and median time to resolution was 23.5 days (iqr 8.5¿33.8).Adverse events occurred in two cases that were developed intracystic bleeding and were successfully resolved by arterial coil embolization.Conclusions: early eus-guided drainage is a technically feasible, effective, and safe method in patients who have developing pafcs within 4 weeks of pancreatobiliary surgery.Symptomatic procedure-related adverse events developed in two patients who received an fcsems placement (4.2%).One of these cases that underwent eus-guided drainage at 7 days after surgery presented with bleeding at 5 days after eus-guided drainage.This patient underwent coil embolization of the left gastric artery and improved.The other patient, who underwent eus-guided drainage at 9 days after surgery, presented with bleeding at 4 days after eus-guided drainage.This patient underwent coil embolization of the left inferior phrenic artery and proximal common hepatic artery.Thereafter, surgical evacuation of the hematoma was performed.18 patients died of recurrence of cancer; however, there were no procedure-related mortalities.There is no report of any olympus device malfunction reported in any procedure described in this literature.

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 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: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 14595903
• MDR Text Key: 293301167
• Report Number: 8010047-2022-09402
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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: 06/13/2022
• 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): Required Intervention; Other