MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q240Z

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

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

Event Date 07/17/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature "utility of underwater emr for nonpolypoid superficial nonampullary duodenal epithelial tumors =20 mm."  literature summary: this retrospective study analyzed the utility of underwater endoscopic mucosal resection for nonpolypoid superficial non-ampullary duodenal epithelial tumors =20 mm.A total of 132 patients (emr 21 patients 23 snadet, uemr 60 patients 61 snadet, emrc 45 patients 48 snadet) were included.For endoscopic resection, upper endoscope (gif q240z, gif q260j, gif h260z, or gif-h290t; olympus ) was used.For emr and emrc, saline and/or 10% glycerin solution (glyceol; chugai pharmaceutical ) with indigo carmine was administered for submucosal injection.For snaring of emr and uemr, a 10- to 20-mm electrocautery snare (maj-11, maj-216, snaremaster; olympus or captivator; boston scientific) was used.In emrc, a transparent cap (maj-291 or maj-296; olympus ) with an outer diameter of 14.8 or 16.1 mm was attached to the tip of the endoscope.A half moon braided snare (sd-7p-1; olympus) was used for snaring.Both uemr and emrc had a significantly higher r0 resection rate than emr.Uemr had significantly lower multiple resection and post-bleeding rates than emr.In terms of adverse events, only one (2.1%) patient who underwent emrc presented with intraoperative and postoperative perforation.Postoperative bleeding was defined as overt hematemesis, or a decreased hemoglobin concentration >2 g/dl after the procedure.Emr was involved in rx/1 and piecemeal resection.The recurrence rates of emr, uemr, and emrc were 4.3%, 2.0%, and 6.3%, respectively.This study concluded that the uemr had significantly higher r0 resection and lower post-bleeding rates than emr.Moreover, it was safer than emrc and was associated with a lower incidence of recurrences.The significant results of the retrospective analysis suggest a randomized controlled study with adequate numbers need to be conducted to confirm the superior efficacy of uemr before it is recommended for primary treatment option for snadet measuring =20 mm.The author responded to a request for additional information stating the adverse events were not caused by the olympus devices.Type of adverse events/number of patients.Endoscopic mucosal resection (emr): postoperative bleeding - 2 patients.Underwater emr (uemr): postoperative bleeding - 1 patient.Cap-assisted emr (emrc): postoperative bleeding - 1 patient.Intraoperative perforation - 1 patient.Delayed perforation - 1 patient. this article includes 7 reports: patient identifier (b)(6):gif-q240z.Patient identifier (b)(6):gif-q260j or gif-h260z.Patient identifier (b)(6):gif-h290t.Patient identifier (b)(6):maj-11.Patient identifier (b)(6): maj-291 or maj-296.Patient identifier (b)(6): sd-7p-1.Patient identifier (b)(6): maj-216 wire.This report is 1 of 7 for patient identifier (b)(6):gif-q240z.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

Correction: e3.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and a correction.New information was added to the following fields: b3, h6, h10.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.

• Brand Name: EVIS GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 14716995
• MDR Text Key: 294851488
• Report Number: 8010047-2022-10182
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-Q240Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• 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
• Treatment: UNKNOWN LOT: MAJ-11, (B)(6), SD-7P-1, (B)(6).; UNKNOWN SERIAL: GIF-Q260J, GIF-H290T
• Patient Outcome(s): Other