MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R95, 12X100 KII BLUNT TIP SM CONE 6/BX; GCJ

Model Number	13
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap hernia.Incident description: "feeding mesh down through seal with a [competitor] grasper, the rubber on the seal dislodged, the surgeon identified the piece sitting in the incision and retrieved it safely." type of intervention: "the surgeon identified the piece sitting in the incision and retrieved it safely." patient status: unknown.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation with a rubber fragment.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.The rubber fragment returned matched the missing portion on the seal.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.

• Brand Name: C0R95, 12X100 KII BLUNT TIP SM CONE 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita 92688
• MDR Report Key: 6494218
• Report Number: 2027111-2017-01695
• Device Sequence Number: 1627531
• Product Code: GCJ
• UDI-Device Identifier: 00607915127602
• UDI-Public: (01)00607915127602(17)190919(30)01(10)1279652
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 13
• 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): 05/26/2017

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: 09/19/2019
• Device Model Number: 13
• Device Catalogue Number: 13
• Device Lot Number: 1279652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1