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	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysterectomy.Event description: translation: according to mrs [name], nurse and present during the incident, during laparoscopic surgery, placement of a cfs12 balloon trocar sheath observation during placement of the optic that the extremity internal (under the balloon) broke into several pieces: a priori 3.According to mrs [name], nurse and present during the incident, loss of operating time (20 minutes more), repositioning of another cfs12 trocar from the same batch and search for the 3 visualized pieces.After identification they were extracted.According to mrs [name], nurse and present during the incident, we had to look for these pieces.3 were recovered by the surgeon.The nurse checked, tried to reconstruct this very damaged and broken end, like a 3d puzzle.The surgeon watched the reconstruction.The end appeared complete, all visible pieces were recovered.Additional information received by email from applied medical representative on 17feb2022: according to dr.[name], present at the incident, the trocar was not used with a robot.The trocar was used as an auxiliary trocar.According to dr.[name], present at the incident, the trocar was used as a first-line trocar in the open insufflation method without obturator.Type of intervention: 3 pieces were recovered by the surgeon.Patient status: according to ms.[name], a pharmacy intern and present during the incident, the patient is doing well but requires prolonged follow-up.
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: hysterectomy.Event description: [translation]: according to mrs [name], nurse and present during the incident, during laparoscopic surgery, placement of a cfs12 balloon trocar sheath observation during placement of the optic that the extremity internal (under the balloon) broke into several pieces: a priori 3.According to mrs [name], nurse and present during the incident, loss of operating time (20 minutes more), repositioning of another cfs12 trocar from the same batch and search for the 3 visualized pieces.After identification they were extracted.According to mrs [name], nurse and present during the incident, we had to look for these pieces.3 were recovered by the surgeon.The nurse checked, tried to reconstruct this very damaged and broken end, like a 3d puzzle.The surgeon watched the reconstruction.The end appeared complete, all visible pieces were recovered.Additional information received by email from applied medical representative on 17feb22: according to dr.[name], present at the incident, the trocar was not used with a robot.The trocar was used as an auxiliary trocar.According to dr.[name], present at the incident, the trocar was used as a first-line trocar in the open insufflation method without obturator.Type of intervention: 3 pieces were recovered by the surgeon.Patient status: according to ms.[name], a pharmacy intern and present during the incident, the patient is doing well but requires prolonged follow-up.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with three green fragments.Visual inspection of the event unit confirmed the complainant¿s experience of a cannula tip fracture.The green fragments were identified to be a portion of the missing cannula tip.Based on the condition of the returned unit, it is possible that the cannula tip fractured due to a large force exerted on it or an instrument or object coming in contact with the tip during the procedure.It is also possible that the cannula was more susceptible to breakage or inserting the cannula without the obturator could have made the cannula 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: 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: 13595597
• Report Number: 2027111-2022-00404
• Device Sequence Number: 16636579
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)240105(30)01(10)1405882
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 01/05/2024
• Device Model Number: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1405882
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPTIC.
• Patient Sex: Prefer Not To Disclose