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

Model Number	175772P
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
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 a laparoscopic cholecystectomy, a small piece of blue rubber seal ripped off from inside the port and gone in to the patient¿s abdominal cavity and was retrieved using laparoscopic graspers to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: that the trocar only was received.The circular was cut.The envelope seal appeared intact.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Replication of the cut circular seal may occur when mishandled during clinical application.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSASEAL PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7553163
• Report Number: 9612501-2018-01056
• Device Sequence Number: 16187273
• Product Code: GCJ
• UDI-Device Identifier: 20884521082592
• UDI-Public: 20884521082592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K963115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 175772P
• Device Catalogue Number: 175772P
• Device Lot Number: J5M0172X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1