MAUDE Adverse Event Report: LSI SOLUTIONS LSI SOLUTIONS; DISPOSABLE 5MM SUTURING DEVICE

Lot Number 421614

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2010

Event Type  malfunction  

Event Description

Pt underwent a total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, lysis of adhesions, 3 separate lsi rds malfunctioned leaving three 0.3cm bullets inside the pt.No long term pt harm.

• Brand Name: LSI SOLUTIONS
• Type of Device: DISPOSABLE 5MM SUTURING DEVICE
• Manufacturer (Section D): LSI SOLUTIONS; victor NY 14564
• MDR Report Key: 6629665
• MDR Text Key: 77306102
• Report Number: MW5070270
• Device Sequence Number: 3
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 421614
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2017
• 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 Outcome(s): Other
• Patient Age: 43 YR