MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; PDO VIOL 3-0 TAPER POINT UNI-DIRECTIONAL

Model Number JVLP-2022

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

A batch review of the reported lot indicated there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection processes.No other complaints were received for this finished good lot.No samples from the lot or magnified photos of the detached device were returned for testing or review.No retained samples are available for testing/review.If samples or photos become available at a later time the devices will be evaluated, photos reviewed and the results will be included in a follow-up report.A potential root cause for a needle detaching when slightly tugged when preparing for use or detaching during the procedure could be that the suture was not fully inserted within the end of the needle during the manufacturing process.It¿s also possible that the needle device is being gripped on or near the swaged area, causing damage to the attachment, which allows the needle to pull free from the suture.Needles have detached from the suture when excessive force was applied, exceeding the strength of the attachments.The ¿precautions¿ section in the ifu for the device states, ¿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.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point¿.Without receiving the actual device for review, receiving magnified photos of the device, receiving devices from the same finished good lot to test/review, or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device, size of the trocar utilized in conjunction to the needle size, the procedure performed or the surgeon¿s technique and experience, a definitive root cause cannot be determined at this time.

Event Description

After the robotic vesicourethral anastomosis is completed, the instrumentation staff notices that the needle is missing when the quill is removed from the abdominal cavity.The needle was searched inside the abdominal cavity, confirmed to be attached to the abdominal wall, and removed from the body.The user was a newly trained on the use of the device.

• Brand Name: QUILL
• Type of Device: PDO VIOL 3-0 TAPER POINT UNI-DIRECTIONAL
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 15562167
• MDR Text Key: 306431436
• Report Number: 3010692967-2022-00044
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10848782034748
• UDI-Public: (01)10848782034748(17)261226(10)C126JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051609
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2022,10/07/2022

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
• Device Operator: Health Professional
• Device Model Number: JVLP-2022
• Device Lot Number: C126JDS
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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): Required Intervention