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

Model Number	B5STS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10260414
• Report Number: 1219930-2020-02757
• Device Sequence Number: 952213
• Product Code: GCJ
• UDI-Device Identifier: 10884521539846
• UDI-Public: 10884521539846
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR