MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 CAPSURE STRAIGHT; STAPLE, IMPLANTABLE

Catalog Number 0113230

Device Problem Unintended Ejection (1234)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, the capsure fixation device deployed two fasteners at the same time.Review of the photos provided show two capsure fasteners deployed together into the mesh.Based on the deployment it is possible the second fastener was deployed into the first fastener inadvertently or that both fasteners deployed at the same time.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in oct, 2022.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The precautions section of the ifu states: ¿compress hand piece trigger in a single, complete and uninterrupted stroke to drive a permanent fastener through the mesh into the tissue.Keep consistent counter pressure on the tip of the device through the entire stroke.Release the trigger allowing it to return completely to its resting position.Repeat this procedure until all required fasteners are deployed" 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.Not returned.

Event Description

As reported, during a laparoscopic (intraperitoneal onlay mesh) procedure, surgeon tried to fixate a ventralight st echo ps mesh using a capsure straight fixation device.It was reported that two fasteners were deployed at the same time and were removed from the patient body.Fourteen fasteners successfully fixated the mesh and there were no loose fasteners.It was reported that there was some delay in the procedure and the procedure was completed using the same device.There was no reported patient injury.

• Brand Name: CAPSURE STRAIGHT
• Type of Device: STAPLE, IMPLANTABLE
• 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: 17116875
• MDR Text Key: 317136085
• Report Number: 1213643-2023-00229
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K142808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0113230
• Device Lot Number: HUGW0400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other