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

Model Number	2
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Laprascopic sigmoid colon resection - "pressure setting at insulflation set at 14.Patient bucked and the alexis blow out.The shealth split.Used second unit and it happened again.Same lot number.Also sending one unit of sterile product from same lot number." type of intervention - na patient status - no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed the complainant's experience of a torn sheath within the ring-to-ring zone and that no pieces of the film were missing.Based on the condition of the returned unit and additional information received from the complainant, it is likely that the reported event was caused by instruments that were used during the procedure.Engineering determined that the stress on the film was caused by the heat of an energy device.When the patient contracted, it is likely that the pressure caused a tear at the stressed point in the film.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: C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6591457
• Report Number: 2027111-2017-01810
• Device Sequence Number: 18888517
• Product Code: KGW
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)191123(30)01(10)1285749
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: 2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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: 11/23/2019
• Device Model Number: 2
• Device Catalogue Number: 2
• Device Lot Number: 1285749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1