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

Model Number	C0600
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.During the manufacturing process, all seals are thoroughly inspected for functionality and performance prior to packaging.Although the root cause of the experience could not be determined, engineering speculates that the drag force experienced by the customer was most likely caused by non-axial insertion of asymmetrical instruments through the trocar, in addition to multiple instrument exchanges removing applied grease.The instructions for use (ifu) warns that extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Procedure performed unknown."instrument catching inside of seal.No adverse event/patient harm reported.".

• 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: 6099696
• Report Number: 2027111-2016-00793
• Device Sequence Number: 841089
• Product Code: GCJ
• UDI-Device Identifier: 00607915114831
• UDI-Public: (01)00607915114831(17)190228(30)01(10)1265176
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2016

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: 02/28/2019
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1265176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2016
• Initial Report FDA Received Date: 11/14/2016
• Patient Sequence Number: 1