MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R95, 12X100 KII BLUNT TIP SM CONE 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R95
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be 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 cholecystectomy.Event description: nurse unit manager said that the trocar snapped upon insertion.Device has been retained to ship back for analysis.Additional information received via email from [applied medical representative] on 28 july 2021: i was told by the nurse unit manager at the time of notification that the patient was fine and no harm done.Patient status: the patient was fine and no harm done.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: nurse unit manager said that the trocar snapped upon insertion.Device has been retained to ship back for analysis.Additional information received via email from [applied medical representative] on (b)(6) 2021: i was told by the nurse unit manager at the time of notification that the patient was fine and no harm done.Patient status: the patient was fine and no harm done.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The wall thickness of the cannula shaft was uneven and did not meet specifications.Based on the condition of the returned unit and the description of the event, it is likely that the cannula fracture was caused by the uneven cannula shaft wall thickness, which was a result of a core pin shift during the injection molding process of the cannula.

• Brand Name: C0R95, 12X100 KII BLUNT TIP SM CONE 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12268959
• Report Number: 2027111-2021-00590
• Device Sequence Number: 4440860
• Product Code: GCJ
• UDI-Device Identifier: 00607915127602
• UDI-Public: (01)00607915127602(17)231228(30)01(10)1405691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: C0R95
• Device Catalogue Number: 101234701
• Device Lot Number: 1405691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1