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

Model Number	179078PF
Medical Device Problem Codes	Detachment Of Device Component (1104); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively in a laparoscopic procedure, the device¿s gas inlet was cracked and the rubber part located under the cover was separating from its place while using 5 mm tool.They replaced the device to complete the surgery and resolved the issue.The patient was alive with no 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, per additional information received intra-operatively in a laparoscopic bariatric procedure, the device¿s gas inlet was cracked and the rubber part located under the cover was separating from its place while using 5 mm tool.The lens disengaged.They replaced the device to complete the surgery and resolved the issue.The patient was alive with no injury.

• 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 0101 ; DO 0101
• MDR Report Key: 6807773
• Report Number: 9612501-2017-05993
• Device Sequence Number: 18866201
• Product Code: GCJ
• UDI-Device Identifier: 10884521082687
• UDI-Public: 10884521082687
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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: 12/31/2021
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J6M1969X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1