MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. OPTIFIX OPEN 20 COUNT; STAPLE, IMPLANTABLE

Catalog Number	0113320
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject product was discarded and not returned for evaluation.As reported, the physician's assistant placed their finger directly over the area where the fastener was deployed.The ifu for the optifix open fixation device precautions: counter pressure should be applied on the target area.Avoid placing hand/finger directly over the area where fastener is being deployed to prevent injury.Based on the information provided, the user did not follow the recommended instructions which caused the reported problem.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Not returned.
Event or Problem Description
It was reported by the bd sales rep.That during an open umbilical hernia repair, the surgeon was using the optifix open fixation device for the first time.The sales rep.Advised the surgeon to use adequate counter pressure.The surgeon's physician's assistant applied counter pressure on top on the fascia and under the skin and subq fat.At the first fire, the physician's assistant was hit in the finger and through her glove with the guide wire.The case was finished and the physician's assistant had her blood drawn.

• Brand Name: OPTIFIX OPEN 20 COUNT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8798237
• Report Number: 1213643-2019-06166
• Device Sequence Number: 19420208
• Product Code: GDW
• UDI-Device Identifier: 00801741128950
• UDI-Public: (01)00801741128950
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K163698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 0113320
• Device Lot Number: HUCS0218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention