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

Catalog Number	0113115
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device fastener did not fixated firmly and failed to penetrate the tissue.The subject device is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.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, during laparoscopic tapp procedure using sorbafix enhanced fixation device the trigger pull felt loose, and fasteners did not fire properly.Reportedly, the fasteners did not penetrate the tissue, and the loose fasteners were removed from patient's body.Another device was used to complete the procedure.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device fastener did not fixated firmly and failed to penetrate the tissue.The subject device is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The loose fasteners received with the device confirmed the reported event that the device failed to fixate.Evaluation of the sample is inconclusive as the device was received with all 15 fasteners having been deployed prior to the sample return.Functional and simulated use testing could not be performed.No manufacturing anomalies were found.A definitve root cause as to why the fasteners did not fixate in use could not be determined.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, during laparoscopic tapp procedure using sorbafix enhanced fixation device the trigger pull felt loose, and fasteners did not fire properly.Reportedly, the fasteners did not penetrate the tissue, and the loose fasteners were removed from patient's body.Another device was used to complete the procedure.There was no patient harm or injury.

• Brand Name: SORBAFIX ENHANCED
• Common Device Name: 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: 24638154
• Report Number: 1213643-2026-00345
• Device Sequence Number: 18582140
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(11)250411(17)270328(10)HUKQ1722
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 0113115
• Device Lot Number: HUKQ1722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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