MAUDE Adverse Event Report: COVIDIEN VERSASTEP 5MM SINGLE USE DILATOR AND CANNULA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number VS101005

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2018

Event Type  Other  

Event Description

Surgeon was performing a laparoscopic tubal ligation, the case was uneventful and near completion.When the surgeon removed the trocar sheath (covidien versastep 5mm/ref vs101005, lot#: j8d1999x) from the abdomen, it was noted by the surgeon that the tip (approximately 2 cm) of the sheath appeared to be missing.A different trocar was then placed in the abdomen through the same opening to rescope and attempt to locate the missing tip.The second trocar used (covidien versastep 5mm/ref vs101005, lot#: j8f0480x) also appeared to be missing about a 3.5 cm segment of the distal tip upon removal.Exploratory laparotomy along with ct were completed in an attempt to locate the alleged missing pieces, however, none could be detected.Upon further investigation, it was noted that the two trocars used in the procedure were intact and no fragments had actually been retained.The second sheath on both devices had apparently retracted within itself.There is no known patient harm.

• Brand Name: VERSASTEP 5MM SINGLE USE DILATOR AND CANNULA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16815427
• MDR Text Key: 314014497
• Report Number: 16815427
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 2088452108283
• UDI-Public: 012088452108283
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023,11/08/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: VS101005
• Device Catalogue Number: VS101005
• Device Lot Number: J8F1999X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Sex: Female
• Patient Race: Black Or African American