MAUDE Adverse Event Report: ORANGE SURGICAL INSTRUMENTS, LLC / SCA, LLC LAP CLOSURE DEVICE; LAPAROSCOPIC, GENERAL, AND PLASTIC SURGERY

Model Number OS-LPCD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

During closure following robotically assisted laparoscopic prostatectomy, the tip of the lap-port closure device detached and went into the surgical site.It was immediately retrieved from the pt by the surgeon.There was no adverse outcome to the pt as a result of this event.Fda safety report id# (b)(4).

• Brand Name: LAP CLOSURE DEVICE
• Type of Device: LAPAROSCOPIC, GENERAL, AND PLASTIC SURGERY
• Manufacturer (Section D): ORANGE SURGICAL INSTRUMENTS, LLC / SCA, LLC ; sanford FL 32773
• MDR Report Key: 9097819
• MDR Text Key: 159563520
• Report Number: MW5089911
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: OS-LPCD
• Device Catalogue Number: OS-LPCD
• Device Lot Number: 1833802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 79