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	03/25/2021
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: laparoscopic cholecystectomy with per-operatoire cholangiogr.Event description: [translation] the operating ward encountered a problem yesterday with a trocar, cfs12 (lot 1405882), when the surgeon removed the trocar at the end of the procedure, he realized that it was broken.We've retrieved the different pieces.Information received from cer form via email from user facility:[translation] "the instrument nurse that prepared the trocars at the beginning of the procedure informed me that they were in a normal state when she gave them to me.I inserted the trocar under vision without issues, i operated without anything out of the ordinary and did not use this trocar to extract the gallbladder or anything else because this was the trocar for the scope.I've used a johan grasper through two operating trocars to insert a drain.I removed the optical trocar under visual control without noticing anything.The moment we wanted to close the fascia of this trocar, we noticed a piece of the trocar in the subcutaneous tissue." "i've had to return to the laparoscopy with two trocars and manipulate the whole of the abdominal cavity to verify the absence or loss of the 2nd piece intra-abdominally.I called my supervisor with whom i re-did the exploratory laparoscopy.In total, the patient was anesthetized for an additional hour for this reason.The 2nd piece was discovered on the floor after closure of the patient." type of intervention: retrieval of separated parts, another exploratory laparoscopy while patient was still under anesthesia.Patient status: patient is fine - no result for this event.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy with per-operatoire cholangiogr.Event description: [translation] the operating ward encountered a problem yesterday with a trocar, cfs12 (lot 1405882), when the surgeon removed the trocar at the end of the procedure, he realized that it was broken.We've retrieved the different pieces.Information received from cer form via email from user facility:[translation] "the instrument nurse that prepared the trocars at the beginning of the procedure informed me that they were in a normal state when she gave them to me.I inserted the trocar under vision without issues, i operated without anything out of the ordinary and did not use this trocar to extract the gallbladder or anything else because this was the trocar for the scope.I've used a johan grasper through two operating trocars to insert a drain.I removed the optical trocar under visual control without noticing anything.The moment we wanted to close the fascia of this trocar, we noticed a piece of the trocar in the subcutaneous tissue." "i've had to return to the laparoscopy with two trocars and manipulate the whole of the abdominal cavity to verify the absence or loss of the 2nd piece intra-abdominally.I called my supervisor with whom i re-did the exploratory laparoscopy.In total, the patient was anesthetized for an additional hour for this reason.The 2nd piece was discovered on the floor after closure of the patient." type of intervention: retrieval of separated parts, another exploratory laparoscopy while patient was still under anesthesia.Patient status: patient is fine - no result for this event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.Based on the condition of the returned unit and the description of the event, it is likely that the cannula tip fractured due to forces exerted on the cannula tip by instrumentation used during the procedure.It is also possible that the cannula was more susceptible to breakage.However, the exact root cause of the cannula tip fracture is unknown.

• 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
• MDR Report Key: 11620175
• Report Number: 2027111-2021-00418
• Device Sequence Number: 3262095
• 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: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 01/05/2024
• Device Model Number: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1405882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOHAN GRASPER, 2 WORKING TROCARS, SCOPE