MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS02
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysterectomy.Event description: event 1 of 2: (b)(4).Event 2 of 2: (b)(4).The surgeons noted a "forced" passage of the needles mentioned in the cfs02 sleeve ref.As a result, there was needle rubbing with the plastic of the sleeve.The needles remained stuck in the trocar, some of them loosened during the manipulations.This type of event occurred twice in 24 hours with 2 references of the sleeve mentioned.No unit of this reference cfs02 was kept.Needles used :[brand name redacted] 2/0 aiguille 31 mm 1/2c ref : jv3016 -[brand name redacted] 0 aiguille 26 mm 1/2c ref : x905h.Type of intervention: surgeons used another cfs02 lot number and everything went well patient status: fine.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: hysterectomy.Event description: event 1 of 2: (b)(4) (report id 2027111-2022-00685); event 2 of 2: (b)(4) (report id 2027111-2022-00686).The surgeons noted a "forced" passage of the needles mentioned in the cfs02 sleeve ref.As a result, there was needle rubbing with the plastic of the sleeve.The needles remained stuck in the trocar, some of them loosened during the manipulations.This type of event occurred twice in 24 hours with 2 references of the sleeve mentioned.No unit of this reference cfs02 was kept.Needles used :[brand name redacted] 2/0 aiguille 31 mm 1/2c ref : jv3016 -[brand name redacted] 0 aiguille 26 mm 1/2c ref : x905h.Type of intervention: surgeons used another cfs02 lot number and everything went well patient status: fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event and a previous occurrence, it is likely that the needles used were too large to fit through the trocar.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event was initially reported based on the description of the event.However, based on further examination of the event, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.Correction: the component code in section h6 was corrected.

• Brand Name: CFS02, 5X100 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: 15160939
• Report Number: 2027111-2022-00685
• Device Sequence Number: 5874642
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)250418(30)01(10)1448394
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 04/18/2025
• Device Model Number: CFS02
• Device Catalogue Number: 101472915
• Device Lot Number: 1448394
• Was Device Available for Evaluation?: No
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLES
• Patient Sex: Unknown