MAUDE Adverse Event Report: COVIDIEN IRIS INTERFACE CABLE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 388103

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the screen turned black during placement.The healthcare provider replaced the cable and there was no harm to the patient.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The supplier checked their testing result and no abnormality was found.All iris interface cables were tested as per validated testing requirements prior releasing for shipment to at supplier site.No sample of this complaint returned for investigation.However, there were samples returned through r&d to the supplier with similar issue and the supplier had derived the issue based on the r&d samples.Based from the supplier analysis performed from the returned samples from r&d, the samples showed swelling on the fuse protective coating on the area of filament which indicates that the filaments were exposed to high temperature resulting to breakdown of fuse filament.The high temperature on the fuse filament is due to high current that is above the manufacturer specification that was applied on the module during the application which was not induce from supplier manufacturing/ testing processes.There are no signs of crack on the fuse component or any mechanical on the area of fuse filament that may cause the material weakness.Electrical verification also confirmed that the fuse components are within the manufacturer specification.As a corrective action, design change was initiated to change the fuse rating from 75ma to 200ma as an interim corrective action.

• Brand Name: IRIS INTERFACE CABLE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9490474
• MDR Text Key: 171860768
• Report Number: 1282497-2019-08829
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521165014
• UDI-Public: 10884521165014
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 388103
• Device Catalogue Number: 388103
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2019
• Patient Sequence Number: 1