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

Model Number	24055
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
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 procedure, when they were removing the device, there was a piece of the trocar, "a locking prong".That broke off into the patient and could not be retrieved.The issue happened at the end of the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PEDIPORT
• 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: 7691170
• Report Number: 9612501-2018-01305
• Device Sequence Number: 19173688
• Product Code: GCJ
• UDI-Device Identifier: 10884521080829
• UDI-Public: 10884521080829
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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 Expiration Date: 04/30/2021
• Device Model Number: 24055
• Device Catalogue Number: 24055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2018
• Supplement Date Received by Manufacturer: 07/01/2018; 08/08/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 07/20/2018; 10/04/2018
• 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: Other