MAUDE Adverse Event Report: COVIDIEN LP VERSASTEP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Lot Number J8K2242Y

Device Problem Break (1069)

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

Event Date 01/24/2019

Event Type  malfunction  

Event Description

Tip of needle broke and ended up inside patient's body.Surgeon was able to retrieve it.

• Brand Name: VERSASTEP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8385845
• MDR Text Key: 137703609
• Report Number: 8385845
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: J8K2242Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1