MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX; KGW, GCJ

Model Number	C8701
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two fda product codes and pma/510(k) numbers are noted as the event product is a kit containing two devices with different product codes, (b)(4) and 510(k) numbers, k093296 and k041795.The event product is anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance with 21 cfr 803.56, if additional information is obtained, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure performed - unknown: - "the consultant during the case "noticed a black fragment in the abdomen.The surgeon was using an endoractor through the port at the time.The port was removed and on inspection it looked like a part of the seal was missing." additional information received via email from sales representative on (b)(6) 2016: "an endoractor which was used to pack the small bowel away from the operating field was inserted through the port.It was after this that the surgeon noticed a small black fragment in the patient.This was then removed from the patient, the trocar was replaced and procedure completed." patient status: "no patient injury or illness occurred associated with the complaint event.".
Additional Manufacturer Narrative
Investigation summary: one alexis® laparoscopic system, kii fios trocar and a seal fragment were returned for evaluation.Engineering disassembled the seal and noted that the septum was found to be torn and missing a portion.The fragment returned along with the event unit matched the missing portion of the septum.All seals are thoroughly inspected and tested for leakage during the manufacturing process.The damage to the septum appears to have been caused by an instrument.There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices.The instructions for use (ifu) warns that extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal to prevent tearing.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
• Common Device Name: KGW, GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6100992
• Report Number: 2027111-2016-00818
• Device Sequence Number: 294427
• Product Code: GCJ
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)190603(30)01(10)1270846
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K041795
• 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): 01/11/2017

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: 06/03/2019
• Device Model Number: C8701
• Device Catalogue Number: 101135801
• Device Lot Number: 1270846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1