MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX LARYTUBE 9/55; LARYNGECTOMY TUBE

Catalog Number	7607
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.The device has not been returned from the patient, so the investigation has not yet been started.However this is a new phenomenon that we have not seen before.All devices are inspected after injection molding and then manually handled in production before sent to customer so this is deemed as an isolated event and will be investigated as soon as the product has been returned.
Event or Problem Description
This is the information that was received from the atos medical local representative: the product was in 6 weeks from purchase, pt removed one pm to clean and noticed piece missing at that time she coughed and felt something fly out (assumption the missing piece).Actual date of event not recalled, item bought at the (b)(6) clinic (b)(6) 2017.Pt used h2o & hydrogen peroxide for cleaning as per teaching.Pt uses water based lubricant to ease insertion.
Additional Manufacturer Narrative
This is an follow up report after we received the device in question for evaluation.Investigation: the provox larytube was visually inspected and it is seen that the larytube has a piece missing at the end of the tube.Conclusion/action: the silicon, which the larytube is made of, can resist extremely high pull force before being torn apart, but if there is a small fraction from where the tear has started this could quite easily be larger.Since the patient has not used the larytube for more than six weeks the suggested cause of the damage would be that the larytube has come in contact with something sharp either when it has been cleaned by the customer or in some other way.Even though it is a lot easier to pull the material apart with a beginning fraction compared to just pulling the material apart, it still needs some force to create the kind of damage seen in this complaint.This is a new phenomenon that we have not seen before.All devices are inspected after injection molding and then manually handled in production before sent to customer so this is deemed as an isolated event.Correction in this report: the date of this report is changed from 09 may 2017 to 10 may 2017.
Event or Problem Description
This is the information that was received from the atos medical local representative: the product was in 6 weeks from purchase, pt removed one pm to clean and noticed piece missing at that time she coughed and felt something fly out (assumption the missing piece).Actual date of event not recalled, item bought at the (b)(6) clinic (b)(6) 2017.Pt used h2o & hydrogen peroxide for cleaning as per teaching.Pt uses water based lubricant to ease insertion.

• Brand Name: PROVOX LARYTUBE 9/55
• Common Device Name: LARYNGECTOMY TUBE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 6676473
• Report Number: 8032044-2017-00010
• Device Sequence Number: 1882974
• Product Code: KAC
• UDI-Device Identifier: 07331791002175
• UDI-Public: 7331791002175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 7607
• Device Lot Number: 1606018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2017
• Device Age: 1 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1