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

Catalog Number 0113230

Device Problems Unintended Ejection (1234); No Apparent Adverse Event (3189)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, the capsure fixation device deployed two fasteners 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.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.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.¿ and "use caution when applying the capsure¿ fastener over or in proximity to underlying bone, vessels, nerves, or viscera.Care should be taken not to use excessive counter pressure as this may damage the tissue, the material being fixated, and/or the device." this mdr is submitted to represent capsure straight (device #1).An additional mdr was submitted to represent capsure straight (device #2).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.H3: not returned.

Event Description

As reported, during an unknown procedure, two capsure fixation device (device #1 and device #2) were used to fixate the mesh.It was reported that, two fasteners were deployed at the same time which was stacked up.There was no reported patient injury.

Manufacturer Narrative

As reported, the capsure fixation device deployed two fasteners 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.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.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.¿ and "use caution when applying the capsure¿ fastener over or in proximity to underlying bone, vessels, nerves, or viscera.Care should be taken not to use excessive counter pressure as this may damage the tissue, the material being fixated, and/or the device." addendum: h11: this is an addendum to the mdr initially submitted for device #2.Clarification has been received that there was an error in indicating that 2 devices (capsure straight) were involved in the event.The clarification confirmed that the reporter meant 2 fasteners were deployed from a single capsure straight device (device #1).As such this semdr is being submitted to report there was no device #2 involved in the event or even present during the case.Corrected fields: b2 (event attributed to adverse event - other details), b3 (date of event), b5 (event description), d5 (medical device operator), d6a (medical device implant date).Any subsequent updates regarding this event will be reported solely under mdr 1213643-2023-00236 which was initially submitted to represent device #1.

Event Description

As reported, during an unknown procedure, two capsure fixation devices (device #1 and device #2) were used to fixate the mesh.It was reported that, two fasteners were deployed at the same time which was stacked up.There was no reported patient injury.Addendum: clarification received from the initial reporter confirmed that only one capsure straight device (device #1) was used during the procedure which is reported to have fired two fasteners.As such there is no device #2 associated with this event.

• 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: 17162081
• MDR Text Key: 317511387
• Report Number: 1213643-2023-00237
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: HUHP1128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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