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

Model Number	98701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, aa8197r09, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by (b)(6) medical inc represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to (b)(6) medical inc.(b)(6) medical inc 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 (b)(6) medical inc complaint database and identified as complaint (b)(4).
Event or Problem Description
(b)(6) medical received a single report that referenced five different incidents, which were associated with separate units, involving an unknown number of patients.This is the third of five reports.Refer to 9611594-2019-00019 for the first patient.Refer to 9611594-2019-00020 for the second patient.Refer to 9611594-2019-00022 for the fourth patient.Refer to 9611594-2019-00023 for the fifth patient.It was reported that over the past two months, two different surgeons have experienced sutures break during laparoscopy placement of feeding tubes.The physicians stated that if the sutures were stronger, they would not break as easily as they have.It was noted that the sutures break "when they're trying to pull the gi up to the fascia".There was no patient injury, but the hospital stays were lengthened for a patient who had abdominal surgery.No additional information was provided.

• Brand Name: GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8324761
• Report Number: 9611594-2019-00021
• Device Sequence Number: 2229406
• Product Code: KGC
• UDI-Device Identifier: 10680651987010
• UDI-Public: 10680651987010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: 98701
• Device Catalogue Number: 991098701
• Device Lot Number: AA8197R09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/10/2019
• Patient Sequence Number: 1