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

Catalog Number C-CAE-14.0-70-FIC

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) investigation is still in progress.

Event Description

Description according to complainant: following an intubation, when withdrawing the device, the device was crushed & bent at the distal end.Additional information received 23mar2016: ".The procedure was performed with an army single lumen ett." patient outcome: a section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Summary of investigational findings; it is not evident, if the frova introducer was actually damaged during use or prior to, since reported that "upon removal of the frova introducer, it was found that the distal extremity of the device was bent & crushed.The other device of the same package are ok." however, at a later date it is reported that "the procedure was performed with an army single lumen ett." no product was returned and without the actual complaint device to assist the investigation it is not possible to comment on the device, which following an intubation "was crushed & bent at the distal end", and the exact reason for the difficulties encountered cannot be determined.It is reported that "the patient did not require any additional procedures due to this occurrence." and "according to the initial reporter, the patient did not experience any adverse effects due to this occurrence." investigation found no evidence to suggest product was not manufactured according to specifications, but cook medical will continue to monitor for similar reports.(b)(4).Summary of investigational findings; it is not evident, if the frova introducer was actually damaged during use or prior to, since reported that "upon removal of the frova introducer, it was found that the distal extremity of the device was bent & crushed.The other device of the same package are ok." however, at a later date it is reported that "the procedure was performed with an army single lumen ett." no product was returned and without the actual complaint device to assist the investigation it is not possible to comment on the device, which following an intubation "was crushed & bent at the distal end", and the exact reason for the difficulties encountered cannot be determined.It is reported that "the patient did not require any additional procedures due to this occurrence." and "according to the initial reporter, the patient did not experience any adverse effects due to this occurrence." investigation found no evidence to suggest product was not manufactured according to specifications, but cook medical will continue to monitor for similar reports.

Event Description

Description according to complainant: following an intubation, when withdrawing the device, the device was crushed & bent at the distal end.Additional information received 23mar2016: ¿¿the procedure was performed with an army single lumen ett.¿ patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.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; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5553687
• MDR Text Key: 42035821
• Report Number: 3002808486-2016-00160
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)181207(10)E3393775
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2016
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening