MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERSAONE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number B5STS

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, device components fell into the cavity of the patient.Intra-abdominal visualization showed small blue fragments and presence of scratches on the plastic at the trocar orifice.Abundant washing was performed to resolve the issue.The event led to extended operating time.

• Brand Name: VERSAONE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10260414
• MDR Text Key: 198483291
• Report Number: 1219930-2020-02757
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521539846
• UDI-Public: 10884521539846
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: B5STS
• Device Catalogue Number: B5STS
• Device Lot Number: J9C0332Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Date Device Manufactured: 03/06/2019
• 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
• Patient Age: 26 YR