MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5992025
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was discarded by the user facility and therefore unavailable for review.Based on the information provided and not having the sample, root cause for the issue experienced by the user cannot be determined.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date there have been no other reported complaints for this is the only reported complaint for this production lot of 113 units released for distribution in march, 2019.Discarded.
Event or Problem Description
It was reported that during a case on (b)(6) 2019 the positioning system of a bard ventralight st w/ echo 2 ps partially detached just after the device was inserted into the abdominal cavity through a 12mm trocar.The entire echo 2 ps was removed without issue and fixation was performed manually.As reported surgeon was a first time user of the device and the mesh was rolled and inserted in the correct fashion.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8739974
• Report Number: 1213643-2019-05522
• Device Sequence Number: 1341914
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 01/28/2020
• Device Catalogue Number: 5992025
• Device Lot Number: HUCZ2219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR