MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 1 PDO VARIABLE LOOP

Model Number	VLP-2015
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the finished good lot and the components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection processes.No sterile devices were returned for testing/review.No photos of the product reported (short barbs) or the incision of the patient during the procedure or post suturing was provided.There were no retained samples available for review.If samples or photos become available at a later time, they will be reviewed, tested and the results will be included in our files.A follow-up report will be submitted at that time.A report of small, shallow or less prominent barbs can be a result of variances within the spooled suture material received from our vendor.Sometime lots of suture measure closer to the minimum requirement.When the thinner suture is being processed and the machine is set to cut the barbs, the barbs are not cut as deep as the barbs on a thicker, more robust piece of suture material within the lot.This would result in variances in how the barbs appear from piece to piece within a lot or box of product.A report of barbs not securing the incision during use could be the result of damaged barbs; possibly damaged when removing the device from the packaging, in preparation of the procedure or if the device is not anchored in the tissue per the ifu for the device.The ¿precautions¿ section in the ifu for the barbed device states, the device contains a loop end and barbs to anchor tissues and does not require knots to approximate opposing edges of a wound.Tying of knots on the barbed section of the material will damage the barbs and potentially reduce their effectiveness.For the device to function properly, the device must first be anchored in the tissue by the deployment of the loop around robust tissue, then with the other subsequently engaged in the tissue by the barbs.Additionally, when completing placement of the barbed segment, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the device in place.Avoid contacting the device with other materials (e.G.Surgical gauze, drapes, etc.) in the surgical field to prevent ensnaring on the barbs.If the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs.Care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments, such as needle holders and forceps.Do not attempt to remove memory in the polymer by running fingers down the suture material as this can damage the barbs".The ¿application¿ section of the ifu for the barbed device states, ¿care should be taken to utilize the device on the barbed segments only.Do not attempt to approximate wounds using the non-barbed segments, as the barbs are required for successful wound approximation.Without reviewing the actual reported device, receiving magnified photos of the actual device, receiving sterile devices from the same finished good lot to test/review or receiving detailed information regarding the method utilized to remove the device from the package, pre-operative preparation of the device(s), method utilized to secure the device in the tissue or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
A quill vlp-2015(lot aafs597) was used for a lap myomectomy.The surgeon reported that the barbs were too small and the traction for holding is not good.She had to go back to vloc to secure haemostasis.There was still haematoma after finishing suturing.The operation was delayed by a lot of time as they needed to resuture with another device.

• Brand Name: QUILL
• Common Device Name: 1 PDO VARIABLE LOOP
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 12170973
• Report Number: 3010692967-2021-00025
• Device Sequence Number: 3838973
• Product Code: NEW
• UDI-Device Identifier: 10848782020864
• UDI-Public: (01)10848782020864(17)250331(10)AAFS597
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021
• Report Date (Section F): 06/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2025
• Device Model Number: VLP-2015
• Device Catalogue Number: VLP-2015
• Device Lot Number: AAFS597
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2021
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/14/2021
• 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