MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R47
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: laparoscopic cholecystectomy.Detailed description of event: hospital: [name] while setting up the backtable for surgery, the scrub tech noticed a very long black hair or thread wrapped around a piece of the plastic that holds all 3 of the pieces together for trocar cor47.Product was passed off the field; gloves were changed.New product procured.Product has been saved for return and pictures are attached.The product is available for return.Additional information received from [name] via email on 11sep2024: the event date is confirmed to be (b)(6) 2024.The procedure being performed was a laparoscopic cholecystectomy.Type of intervention: product was passed off the field; gloves were changed.New product procured.Patient status: before use.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: laparoscopic cholecystectomy.Detailed description of event: hospital: [name].While setting up the backtable for surgery, the scrub tech noticed a very long black hair or thread wrapped around a piece of the plastic that holds all 3 of the pieces together for trocar cor47.Product was passed off the field; gloves were changed.New product procured.Product has been saved for return and pictures are attached.The product is available for return.Additional information received from [name] via email on 11sep2024: the event date is confirmed to be 06sep2024.The procedure being performed was a laparoscopic cholecystectomy.Type of intervention: product was passed off the field; gloves were changed.New product procured.Patient status: before use.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of a loose hair on the device.Based on the condition of the returned unit and the description of the event, it is likely that the loose hair originated from an operator during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.

• Brand Name: C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 20306828
• Report Number: 2027111-2024-00846
• Device Sequence Number: 7624149
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453(17)270617(30)01(10)1523326
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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 Model Number: C0R47
• Device Catalogue Number: 101477456
• Device Lot Number: 1523326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown