MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; LRC INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number C-CAE-14.0-70-FII

Device Problem Material Frayed (1262)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the product was broken at its distal end during the procedure (intubation)."the product had got damaged during intubation.The distal end was significantly damaged and broken and might end up fractured in the trachea while they used it".Patient outcome: unknown.

Event Description

Description of event according to initial reporter: the product was broken at its distal end during the procedure (intubation)."the product had got damaged during intubation.The distal end was significantly damaged and broken and might end up fractured in the trachea while they used it".Additional information received from customer 21apr2018: "their reply was that there was no adverse effect on patient due to frova damage and they did not used double lumen endo tracheal tube during the procedure".Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) (b)(4).Summary of investigational findings: investigation confirmed the reported damage as the introducer was found kinked approx.10cm from the distal end and approx.60cm from the proximal end.The stiffening cannula is 60cm long and placed inside the introducer, ie the introducer is kinked/damaged where the cannula ends.Also, the introducer was damaged approx.24cm from proximal end, as if somehow cut, but this damage was not reported.The exact reason for the kink close to the introducer tip cannot be determined, but it may have occurred if the cannula was not removed, when the introducer was advanced into the trachea or maybe prior to use, if removed from the packaging and prepared for placement in a pocket or so without removing the stiffening cannula.No evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).Patient code: 2199 - no consequences or impact to patient.Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).Patient code: 2199 - no consequences or impact to patient.Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received from customer 21apr2018: "their reply was that there was no adverse effect on patient due to frova damage and they did not used double lumen endo tracheal tube during the procedure" patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7420874
• MDR Text Key: 105570215
• Report Number: 3002808486-2018-00444
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002236462
• UDI-Public: (01)00827002236462(17)201110(10)E3653096
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Catalogue Number: C-CAE-14.0-70-FII
• Device Lot Number: E3653096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Distributor Facility Aware Date: 03/28/2018
• Device Age: 4 MO
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1