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

Model Number	C8502
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Laparoscopic colectomy - "during use the device was totally torn without traction." original: lors de l'utilisation, le dispositif s'est totalement déchiré sans traction.Additional information received from the applied medical team member on january 9, 2017: the customer used the device on laparoscopic colectomy but doesn't remember the details.The part of the device that was torn was confirmed to be the sheath.User does not remember if the device was torn before, during or after insertion.Patient status - no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned.Upon visual inspection, engineering confirmed that there was a tear in the sheath near the inner ring, as well as two small punctures on the sheath inside the ring-to-ring zone.Engineering's analysis has determined that it is likely the tear in the sheath was caused by the instrumentation used by the surgeon.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: 6283053
• Report Number: 2027111-2017-00028
• Device Sequence Number: 19074754
• Product Code: KGW
• UDI-Device Identifier: 00607915119935
• UDI-Public: (01)00607915119935(17)190729(30)01(10)1276025
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/29/2017

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: 07/29/2019
• Device Model Number: C8502
• Device Catalogue Number: 101357101
• Device Lot Number: 1276025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1