MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	ILS-1800-PN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device return has been requested but has not yet been received.A review of the appropriate device history records of the device lot indicates this device was released meeting all quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A medwatch form was received stating a patient underwent an elective bronchoscopy."afterword's" the airways were revisualized and there was no evidence of active bleeding or bronchoscopic trauma.The robotic endoscope was then retracted back through the endotracheal tube without difficulty.Patient tolerated the procedure well and was sent to pacu in stable condition.It was noted that the tip of the needle on the arcpoint system broke while sampling the mass and the tip of the needle was left inside of the large left upper lobe mass.Patient was evaluated by the nurse and thoracic surgery and they agreed leaving the needle in place with its low likelihood of migration was a less risky option "that" exploratory approach.The patient was discharged the same day.
Additional Manufacturer Narrative
The product was returned and evaluated.The needle was not present on the device, which confirms the complaint of the needle detaching from the device.Deformation and exposed braid of the distal tip of the device were observed.A partial cut was also noted at the distal tip of the device.Pressure or grip marks were noted 69 cm from the distal tip of the device.Two (2) kinks were noted near the flush mark of the device.It is unknown how the aforementioned damage occurred.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: SUPERDIMENSION
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 8250315
• Report Number: 3004962788-2019-00001
• Device Sequence Number: 11164664
• Product Code: EOQ
• UDI-Device Identifier: 10884521723627
• UDI-Public: 10884521723627
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2020
• Device Model Number: ILS-1800-PN
• Device Catalogue Number: ILS-1800-PN
• Device Lot Number: SD10-17-144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPERDIMENSION INREACH; SUPERDIMENSION INREACH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 100