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

Model Number	179095P
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	07/26/2019
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 laparoscopic ovarian wedge resection, the cannula was broken and fell into the patient's cavity during taking out the device from the patient.An x-ray was done to allocate the broken piece.However, the attending physician and with the help of general surgeons, unsuccessfully sought the part of the device that was detached.Surgical time was extended due to the product issue.The patient went to recovery, presenting tachycardia.As reported, the patient was kept under observation for two additional days in the clinic.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photos noted: the first image depicts the distal end of the cannula on a piece of gauze.There is a highlighted circle drawn around a gouge and missing piece of the cannula.The second image depicts a close-up view of the gouged 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 gouge at the distal end of the cannula may occur when mishandled during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended 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 PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8947349
• Report Number: 9612501-2019-01655
• Device Sequence Number: 189274
• Product Code: GCJ
• UDI-Device Identifier: 10884521081284
• UDI-Public: 10884521081284
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K952977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 09/30/2023
• Device Model Number: 179095P
• Device Catalogue Number: 179095P
• Device Lot Number: J8J2142X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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: Required Intervention
• Patient Age: 43 YR