MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES OEM 400161-03, INTUITIVE SEAL 5MM; GCJ

Model Number	OEM 400161-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.This report is to follow up medwatch (b)(4).
Event or Problem Description
Procedure performed: ni.Event description: this cer was created for the medwatch received 18 dec 2017 via mail under (b)(4).The event date was (b)(6) 2017."a piece tore off and fell into the abdomen.It was removed and the entire item was removed from the field" "the device is a 5 mm cannula seal for a da vinci case, the size of the piece that fell into patient is approximately the size of a pencil led." "device failed (e.G.Broke, couldn't get it to work or stopped working)" this was not a laboratory device or test.The patient is not (b)(6).Additional information received via telephone on 20dec2017 at 9:05 am from clinical engineer at (b)(6) med ctr: the device is available for return.Type of intervention: "it was removed and the entire item was removed from the field" patient status: ni.
Additional Manufacturer Narrative
Correction: health professional was changed from no to yes.Report sent to fda was changed from unk to yes.The event unit was returned to applied medical for evaluation, along with a rubber fragment.Visual inspection confirmed the complainant's experience of seal component separation.The rubber fragment completed the missing portion on the duckbill, a rubber component of the seal.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." 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.This report is to follow up medwatch report #(b)(4).
Event or Problem Description
Additional information was received via email on 18jan2018 at 7:34am from clinical engineer: patient status is unknown.No patient injury or illness occurred associated with the complaint event.The fragment was retrieved and entire seal removed."i believe the case was on a peds pt, non davinci, will need to confirm." concomitant devices used are unknown.Additional information was received via email on 23jan2018 at 7:17am from clinical engineer: "sorry we can't get you more information, but the internal report did not provide any patient information whatsoever, not even a mrn." "patient did fine." no patient injury or illness occurred associated with the complaint event.Concomitant devices used were "utd".

• Brand Name: OEM 400161-03, INTUITIVE SEAL 5MM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7201115
• Report Number: 2027111-2018-00022
• Device Sequence Number: 1016434
• Product Code: GCJ
• UDI-Device Identifier: 00607915119775
• UDI-Public: (01)00607915119775(17)190404(30)01(10)1267415
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K060534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 04/04/2019
• Device Model Number: OEM 400161-03
• Device Catalogue Number: 100786801
• Device Lot Number: 1267415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1