MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8502, M ALEXIS LAP SYS 6/BX; KGW

Model Number	C8502
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the event device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: lap donor nephrectomy event description: part of cap broke off and fell in patient.They use the cap to introduce cd004 without trocar.Addition information received on tuesday, july 4, 2017 that the hospital does not know for sure at what point the cap broke off, they noticed it because there was a leakage after tissue removal with inzii.They did not use any other instruments.With respect to experience the surgeon used the product around the 3rd or 4th time.Only the cap will be removed, they threw away the piece that broke off, so they only saved the cap.Comment from the hospital: ''we removed the kidney as usual through the port and placed the cap back on the alexis.We noticed that there was a leakage, very unpleasant.When we checked the cap for the leakage we noticed that a part of the cap was broken off.A piece of the seal.''.Type of intervention: unknown.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
Investigation summary: the laparoscopic cap from the event unit was returned for evaluation.Upon inspection, engineering confirmed the complainant's experience of a broken cap, as a small piece was missing from the cap.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the device that was inserted into the cap without a trocar.The instructions for use (ifu) states that the alexis laparoscopic system is "intended to be used during a laparoscopic surgery to seal the retracted wound or to convert the retracted wound into an additional trocar port for a 12mm trocar".Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C8502, M ALEXIS LAP SYS 6/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6709305
• Report Number: 2027111-2017-01900
• Device Sequence Number: 16403567
• Product Code: KGW
• UDI-Device Identifier: 00607915119935
• UDI-Public: (01)00607915119935(17)191214(30)01(10)1285187
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K093296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

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: Other
• Device Expiration Date: 12/14/2019
• Device Model Number: C8502
• Device Catalogue Number: 101357101
• Device Lot Number: 1285187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1