MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE260-AL5

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp (omsc).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "wound closure with the over-the-scope clip (otsc) system was effective for duodenal perforation during endoscopic ultrasound examination: a case report".The literature reported the result of a patient of the ultrasonic endoscopy procedure using olympus ultrasonic gastrovideoscope gf-ue260-al5.In the subject cases, a perforation occurred during the procedure.Omsc will submit a medical device reports (mdr) depending on the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Corrections are being made to b5, e4, h6 and h8.The device history record was unable to be reviewed for this device since the 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.Olympus will continue to monitor field performance for this device.

Event Description

Olympus received the document "18 cases in which wound closure by over-the-scope clip (otsc) system was effective for duodenal perforation during ultrasonic endoscopy".Gastrointestinal perforation is one of the serious complications associated with biliary-pancreatic endoscopy and treatment.There is endoscopic suturing as a treatment, and over-the-scope clip (otsc) system (century medical) is an endoscopic treatment device that enables full-thickness suturing of the intestinal wall.We report high clinical efficacy and safety for hemostasis of insufficiency and refractory bleeding.Endoscopic papillectomy (ep) was performed for papillary adenoma.At the time of periodical inspection two years after the ep, a radial ultrasonic endoscope (ue-260) was used to make an inspection, and during the stretching operation on the duodenum, the perforation was made in the superior duodenum, and the scope deviated into the abdominal cavity.After the perforation is known, the endoscopic treatment can be observed by attaching the tip cap to the upper gastrointestinal endoscope, and the perforation site can be identified.Then, both ends of the normal mucous membrane around the perforation part are put into the application cap by attaching otsc.As much as possible and placed otsc.On the day after the treatment, fever of 38 degrees and mild epigastric pain were observed, but the day after the day after the next day, the fever was resolved and the symptoms improved.The symptoms disappeared 3 days after the treatment, the gastric tube was removed, and drinking water and oral administration of p°ab were started.He resumed eating on the 4th day after the procedure and was discharged from the hospital on the 7th day.For the duodenal perforation during eus, we experienced a case in which a wound was closed with otsc and surgery was avoided.Careful use of otsc with careful indication is expected to be an alternative to surgical treatment.Regarding adverse events, the following was mentioned: perforation in 1 case.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC 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: 10389170
• MDR Text Key: 203306974
• Report Number: 8010047-2020-05425
• 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,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

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
• Device Operator: Health Professional
• Device Model Number: GF-UE260-AL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 06/07/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Female