MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0600, UNIVERSAL SEAL 20/BX; GCJ

Model Number	C0600
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be provided upon completion of investigation.This report is to follow up medwatch #(b)(4).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
Laparoscopic cholecystectomy- "event desc: this was a laparoscopic cholecystectomy case.The doctor found out the universal seal - a piece of disposable part that goes in with the (b)(6) - came out with a tear and missing rubber part." "what was the original intended procedure- laparoscopic cholecystectomy.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working)" additional information received via email from user facility on (b)(6) 2016: it is unknown what instruments were being used at the time of the event.No pieces of the seal fell into the patient.There was no harm to the patient.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.The likely root cause of the damage to the seal is an instrument.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.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.This report is to follow up (b)(4).

• Brand Name: C0600, UNIVERSAL SEAL 20/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6216607
• Report Number: 2027111-2016-00907
• Device Sequence Number: 16237767
• Product Code: GCJ
• UDI-Device Identifier: 00607915114831
• UDI-Public: (01)00607915114831(17)190420(30)01(10)1268520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K932995
• 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): 02/20/2017

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: 04/20/2019
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1268520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 02/20/2017
• Patient Sequence Number: 1