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

Model Number	388103
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9490474
• Report Number: 1282497-2019-08829
• Device Sequence Number: 16889244
• Product Code: KNT
• UDI-Device Identifier: 10884521165014
• UDI-Public: 10884521165014
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 388103
• Device Catalogue Number: 388103
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1