MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR03
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device was returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "laparoscopic hernia repair(tapp or tep)" event description: " this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Shield removed.Report from the sales rep.Laparoscopic hernia repair(tapp or tep) was performed.During removal of a hernia tacker(manufacturer: unknown), the customer felt strong resistance and a transparent component broke off inside abdomen.The unit was changed out to new one and the case was successfully complete.The fragment was removed from patient.No patient injury.Initial investigation report.The event unit was returned to us and visually inspected.The shield was removed from the seal, but not fragmented.No damage was observed with the ddb and the septum.The unit will be returned to amr for further evaluation.(b)(4)." type of intervention: "the unit was changed out to new one and the case was successfully complete." patient status: "no patient injury".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a damaged shield, a clear plastic internal component of the seal.Visual inspection confirmed the complainant's experience of seal component separation.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.

• Brand Name: CTR03, 5X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7242967
• Report Number: 2027111-2018-00034
• Device Sequence Number: 16451265
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)200504(30)01(10)1296358
• Combination Product (Y/N): N
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 05/04/2020
• Device Model Number: CTR03
• Device Catalogue Number: 101138201
• Device Lot Number: 1296358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1