MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB33, 11X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
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: unknown.Event description: [translation] the laparo trocard broke in the patient's abdomen.The piece was found (risk of leaving a foreign body in a patient) protective measures and actions taken: declaration of medical device vigilance, medical device taken to the pharmacy type of intervention: the piece was found.Patient status: unknown.
Event or Problem Description
Procedure performed: laparoscopy for endometriosis with hysterectomy.Event description: [translation] the laparo trocard broke in the patient's abdomen.The piece was found (risk of leaving a foreign body in a patient) protective measures and actions taken: declaration of medical device vigilance, medical device taken to the pharmacy additional information received by email from applied medical representative on 20dec21: it was a laparoscopy for endometriosis with hysterectomy and bilateral salpingectomy.We had to look for the missing part of the trocar in the patient's abdomen, we took at least 5 min to find it and we changed the trocar with a diam 10 trocar.It is a part of the cannula after the balloon that is in the patient's abdomen.Additional information received by email from applied medical representative on 02feb22: event date : (b)(6) 2021.There is no memory of a "shock" with another instrument during the intervention.Type of intervention: retrieval of separated part.Patient status: we had to look for the missing part of the trocar in the patient's abdomen, we took at least 5 min to find it and we changed the trocar with a diam 10 trocar.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a fragment.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The fragment completed the missing portion of the cannula tip.Based on the condition of the returned unit, it is likely that the cannula tip fractured due to a large force exerted it or instrumentation coming in contact with the cannula tip during the procedure.It is also possible that the cannula was more susceptible to breakage.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CFB33, 11X100 KII SH BLD ADVFIX 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13014964
• Report Number: 2027111-2021-00776
• Device Sequence Number: 4949088
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)240728(30)01(10)1420434
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083638
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 07/28/2024
• Device Model Number: CFB33
• Device Catalogue Number: 101473821
• Device Lot Number: 1420434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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: Prefer Not To Disclose