MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST W/ ECHO 2; SURGICAL MESH

Catalog Number	1210011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, echo 2 positioning system detached from the phasix st mesh when pulled through the trocar.The sample was not available for evaluation.However, based on the information provided, the user grasped only the echo 2 when pulling into the abdomen which is contraindicating with the grasping technique provided in the instructions-for-use supplied with the device which states to "hold the tightly rolled device and firmly grasp the leading edge with an atraumatic grasper or equivalent tool.Take care to grasp both the mesh and positioning system at approximately a 45 degree angle".Hence, the reported event is determined to be use related with no malfunction of the device.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 43 units.Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
As reported, a laparoscopic ventral hernia repair was performed on (b)(6) 2025.During this procedure, it was reported that the echo 2 detached from the phasix st mesh.The detachment occurred when the surgeon inserted the mesh into the 12 mm trocar, and when it was grasped to pull it through only the echo 2 was grasped not the mesh.A new phasix st w/ echo 2 was used to complete the procedure.There was no patient injury.

• Brand Name: PHASIX ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23826300
• Report Number: 1213643-2025-01232
• Device Sequence Number: 9267739
• Product Code: OWT
• UDI-Device Identifier: 00801741161216
• UDI-Public: (01)00801741161216(17)270528(10)HUKT1044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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 Catalogue Number: 1210011
• Device Lot Number: HUKT1044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown