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

Model Number	177794
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	10/24/2018
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, after a laparoscopic oophorocystectomy the breakage of the trocar tip was confirmed.Because it was postoperative, the second procedure was performed.During the second procedure, the patient¿s cavity was observed, but no fragments were found.The fragments found in the operation room fitted the damaged part, but the size did not match.The part fell into the patient's cavity and could not be retrieved.
Additional Manufacturer Narrative
Device evaluation: post market vigilance (pmv) led a photographic evaluation of four photographs of a device.A visual inspection of the returned photos the first photo depicts a gouge at the distal end of the cannula.The second photo depicts a gouge at the distal end of the cannula, with two fragmented pieces.The third photo depicts two fragmented pieces.The fourth photo depicts the gouged cannula with a fragmented piece on top of the gouge and a fragmented piece next to the cannula.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the gouged cannula tip may occur if the device is mishandled or handled roughly during application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAPORT
• 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: 8077792
• Report Number: 1219930-2018-06129
• Device Sequence Number: 1106782
• Product Code: GCJ
• UDI-Device Identifier: 10884521078475
• UDI-Public: 10884521078475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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 Model Number: 177794
• Device Catalogue Number: 177794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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