MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD THORACOPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	179303
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic wedge resection on left side, while inserting the device into the patient the cannula was broke and a piece of plastic fall into the patient cavity and was retrieved.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic wedge resection on left side, while inserting the device into the patient the cannula was broke and a piece of plastic fall into the patient cavity and was retrieved by grasper, however it was also reported that there is a possibility that a piece of plastic is still in the patient cavity.
Additional Manufacturer Narrative
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection noted: that one device was received unopened in its original packaging.The second device only the cannula was received, and it was observed that the distal end of the cannula was gouged and disengaged, also the proximal end had the center partially disengaged.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 and disengaged cannula tip may occur when mishandled during clinical 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: THORACOPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo PR 0101 ; DO 0101
• MDR Report Key: 7984660
• Report Number: 2647580-2018-05055
• Device Sequence Number: 1707234
• Product Code: GCJ
• UDI-Device Identifier: 10884521081185
• UDI-Public: 10884521081185
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2019

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: 10/01/2020
• Device Model Number: 179303
• Device Catalogue Number: 179303
• Device Lot Number: P5K0417X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 12/11/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/04/2018; 01/07/2019
• 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: Other
• Patient Age: 29 YR