MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; KGW

Model Number	C8501
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap hemi colectomy event description: "the sheath was torn during the surgery." additional information was received via email from sales manager on tuesday (b)(6) 2017: the surgeon/staff realize the sheath was torn during the surgery, after being inserted to the patient body.There was no damage on the cap.Common laparoscopic instruments were used through the trocar on the cap.The sheath particulated and all material was retrieved.Type of intervention: unk.Patient status: "no patient injury".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath was torn from ring to ring along the seam.Based on the condition of the returned unit, it is likely that the reported event was caused by instruments that were used during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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.
Event or Problem Description
Additional information was received via email from sales manager on tuesday august 29, 2017: - at what point during the case did the surgeon/staff realize the sheath was torn? during the surgery, after being inserted to the patient body.- was the cap on the product when the surgeon/staff realized the sheath was torn? no.There was no damage on the cap.- did any instrumentation come in contact with the sheath? if so, was the instrumentation being placed through a trocar through the cap? common laparoscopic instruments were used through the trocar on the cap.- did the sheath particulate? yes.Sheath particulated.- was all material retrieved yes.Retrieved.

• Brand Name: C8501, S 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: 6843986
• Report Number: 2027111-2017-01970
• Device Sequence Number: 800944
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)190705(30)01(10)1273550
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 11/14/2017

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: 07/05/2019
• Device Model Number: C8501
• Device Catalogue Number: 101357001
• Device Lot Number: 1273550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1