MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS12, 11X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: hysterectomy laparoscopy.Event description: [translation] during the intervention, the part of the trocar that remains inside the patient between the balloon and the end of the obturator fragmented falling pieces into the abdomen, all of them were removed with the consequential risk of perforation, infection, etc.They report to the aemps through the notificaps portal.Additional information received by email from applied medical representative on 10 sep 2021: today i have been in hospital.I have different's meetings with, [human resources], [operating room nurses] and (b)(6).[a], gynecologist who did the surgery last (b)(6) 2021.The other gyn was (b)(6).[b].During the operation, a laparoscopy hysterectomy, towards the end when they were checking the hemostasis they watched that there was a strange plastic piece, when they extracted it they saw that it was a piece from one of the trocars.They saw that one of the pieces was missing and searched the abdomen for a while, when they did not find it they decided that need to do a laparotomy to find it, they made it and the missing piece appeared.Dra.[a] told me that they had warned urology because they had to check the bladder (nothing to do with the incident) and that taking advantage of this they decided this way to solve both things.They didn¿t feel that the trocar was forced or anything was broken during the operation.The patient is doing well, recovering.They are worried because they have units of the same batch left and don¿t know if they will work properly.Additional information received by email from applied medical representative on (b)(6) 2021: the procedure being performed was a hysterectomy laparoscopy.They dont know how it broke because they didn't notice anything strange during the intervention, they didn't feel that they forced any trocar.No robot used, there¿s an ancillary trocar.As a method of insertion, they used fios introduction.Type of intervention: they decided that need to do a laparotomy to find it, they made it and the missing piece appeared.Patient status: the patient is doing well, recovering.No patient injury or illness associated with the complaint event.
Event or Problem Description
Procedure performed: histerectomy laparoscopy.Event description: [translation] during the intervention, the part of the trocar that remains inside the patient between the balloon and the end of the obturator fragmented falling pieces into the abdomen, all of them were removed with the consequential risk of perforation, infection, etc.They report to the aemps through the notificaps portal additional information received by email from applied medical representative on 10 sep 2021: today i have been in hospital [ ].I have differents meetings with, [human resources], [operating room nurses] and dra.[a], gynecologist who did the surgery last (b)(6) 2021.The other gyn was dra.[b].During the operation, a laparoscopy hysterectomy, towards the end when they were checking the hemostasis they whatched that there was a strange plastic piece, when they extracted it they saw that it was a piece from one of the trocars.They saw that one of the pieces was missing and searched the abdomen for a while, when they did not find it they decided that need to do a laparotomy to find it, they made it and the missing piece appeared.Dra.[a] told me that they had warned urology because they had to check the bladder (nothing to do with the incident) and that taking advantage of this they decided this way to solve both things.They didn¿t feel that the trocar was forced or anything was broken during the operation.The patient is doing well, recovering.They are worried because they have units of the same batch left and don¿t know if they will work properly.Additional information received by email from applied medical representative on 13 sep 2021: the procedure being performed was a histerectomy laparoscopy.They dont know how it broke because they didn't notice anything strange during the intervention, they didn't feel that they forced any trocar.No robot used, there¿s an ancillary trocar.As a method of insertion, they used fios introduction.Type of intervention: they decided that need to do a laparotomy to find it, they made it and the missing piece appeared patient status: the patient is doing well, recovering.No patient injury or illness associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with two green fragments.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.The fragments completed the missing portion of the cannula tip.Based on the condition of the returned unit, it is possible that the cannula tip fractured due a large force applied to the cannula tip.It is also possible that the cannula was more susceptible to breakage.However, the exact root cause of the cannula tip fracture is unknown.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CFS12, 11X100 KII SLEEVE ADVFIX 12/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: 12508361
• Report Number: 2027111-2021-00637
• Device Sequence Number: 5159404
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)240518(30)01(10)1415109
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 05/18/2024
• Device Model Number: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1415109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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: Unknown