MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)

Model Number	125239
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, "use of this new double light tube equipment for surgeries where selective intubation is essential; this tube has an ergot too rigid, which is traumatic." it was reported that the y connector disconnected twice and there were difficulties to access to the head of the patient during robot surgery.It was reported that there was no injury to the patient and it was stated that the patient did not experience any complications, no medical or surgical intervention was needed to prevent a permanent impairment of a function, and the event did not lead to or extend patient hospitalization.
Event or Problem Description
Additional information was stated that the level of desaturation was one desaturation; spo2 level = 10%.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one sample was evaluated.The product is used in treatment.The reported condition was not confirmed.Product meets specification.The investigation found the device to function normally.No corrective action is required, because no failure mode was identified, since the product tested satisfactory.The reported failure was not related to the reported complaint event.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7180205
• Report Number: 8020889-2018-00004
• Device Sequence Number: 16393225
• Product Code: BTS
• UDI-Device Identifier: 10884522008792
• UDI-Public: 10884522008792
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K771219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: 125239
• Device Catalogue Number: 125239
• Device Lot Number: 201707319X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 12/20/2017; 04/13/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/12/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR