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

Model Number GIF-XQ260

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

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Pneumonia (2011)

Event Type  Injury  

Event Description

Olympus reviewed the following literature: "comparison of pull and introducer techniques for percutaneous endoscopic gastrostomy." literature summary.The study aimed to compare indications, success rates and complications of pull [p] and introducer [i] techniques for percutaneous endoscopic gastrostomy (peg).A total of 103 inpatients were included in this study (p group, n = 67; i group, n = 36).The rates of tube replacement within first six months in the p and i groups were 1.5% and 11.1%, respectively (p = 0.049).The most common primary indication of peg was malignancy.The proportion of patients with esophageal cancer was significantly lower in the p group (24.4% vs 54.2%, p = 0.015).No significant difference was found in the overall, major, or minor complications between the two groups.In patients with esophageal stenosis, the pull method was a risk factor for complications (p = 0.03; odds ratio [or] = 12, 95% confidence interval [ci]: 1.164¿123.684).Logistic regression analysis showed that the risk factors for major and minor complications were the admission-togastrostomy interval (or = 1.078, 95% ci: 1.016¿1.145, p = 0.014) and lack of antibiotic use (or = 4.735, 95% ci: 1.247¿17.979, p = 0.022), respectively.Both peg techniques have high clinical success rates.The introducer technique is more suitable for patients with esophageal stricture, which has lower minor complications, but higher rate of tube replacement compared to the pull technique.Use of antibiotics may reduce minor complications following peg.Early peg insertion may help to reduce post-peg major complications.Type of adverse events/number of patients, pull-peg, major complications, bleeding from the puncture site - 3 patients, aspiration pneumonia - 2 patients.Minor complications, abscess, wound infection - 3 patients, diarrhea - 2 patients, tube blockage - 1 patient, pain - 18 patients.Introducer-peg, major complications, bleeding from the puncture site - 1 patient, aspiration pneumonia - 3 patients.Minor complications, tube dislodgement - 2 patients, pain - 8 patients.Two complaints were created for mdr.(b)(6):gif-xq260.(b)(6): gif-hq290.This complaint is (b)(6).

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.

Manufacturer Narrative

This is a supplemental report to provide additional information from the author.After receiving additional information from the author, the adverse events reported in the literature article have been determined not to be serious injuries.

Event Description

Additional information was received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events in this literature.The author believes the complications mentioned in the article are caused by the patient's own condition.The author stated there was no malfunction of the olympus device.

• Brand Name: EVIS LUCERA 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: 14915719
• MDR Text Key: 295248727
• Report Number: 8010047-2022-11302
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-XQ260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• 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: GASTROSTOMY TUBE KIT
• Patient Outcome(s): Other