MAUDE Adverse Event Report: AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS; DH EF PERC PLACEMENT PRODUCTS

Model Number 98701

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 03-apr-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

Event Description

Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 9611594-2020-00057 for the second event.Refer to 9611594-2020-00058 for the third event.It was reported by the clinician the saf-t-pexy t-fasteners break during the procedure.The problem has been ongoing for months.There was no reported injury.

• Brand Name: GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9927132
• MDR Text Key: 195893895
• Report Number: 9611594-2020-00056
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770987019
• UDI-Public: 00350770987019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98701
• Device Catalogue Number: 109870104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1