MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abscess (1690); Necrosis (1971); Paralysis (1997); Septic Shock (2068); Dizziness (2194); Coma (2417); Obstruction/Occlusion (2422); Wound Infection (2447); Ischemic Heart Disease (2493); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Cardiovascular Dysfunction/Insufficiency (4445); No Clinical Signs, Symptoms or Conditions (4582); Bacteremia (4846)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
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: lap bilateral salpingectomy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Two similar events occurred at the same facility during the same procedure."when trying to insert trocar into palmers point, trocar fractured.Another trocar was utilized, again trocar fractured into pieces.Both trocars were unable to a third trocar, was utilized and successfully entered the pt.Abdominal cavity.".Additional information was received via email on 24jul2023 from an applied medical representative: the break occurred at the obturator & tip.The hospital was not sure if there was any difficulty noted during the insertion of the device.The break was not considered to be clean as it was cracked/fractured and caused particulation.When asked if all the fragments were retrieved the hospital stated they were "unable to find within the incision sight." n/a noted for patient injury and the patient was discharged.The procedure was a lap bilateral salpingectomy.Clarification on the initial event description was received stating "both trocars were unable to penetrate through the fascia so the trocar could enter into the peritoneal cavity.".Intervention: replaced with a new one to complete the case.Patient status: n/a, discharged.
Event or Problem Description
Procedure performed: lap bilateral salpingectomy.Event description: complaint 1 of 2: (b)(4) (mfr report # 2027111-2023-00533).Complaint 2 of 2: (b)(4) (mfr report # 2027111-2023-00534).Two similar events occurred at the same facility during the same procedure."when trying to insert trocar into palmers point, trocar fractured.Another trocar was utilized, again trocar fractured into pieces.Both trocars were unable to a third trocar, was utilized and successfully entered the pt.Abdominal cavity." additional information was received via email on 24jul2023 from an applied medical representative: the break occurred at the obturator and tip.The hospital was not sure if there was any difficulty noted during the insertion of the device.The break was not considered to be clean as it was cracked/fractured and caused particulation.When asked if all the fragments were retrieved the hospital stated they were "unable to find within the incision sight." n/a noted for patient injury and the patient was discharged.The procedure was a lap bilateral salpingectomy.Clarification on the initial event description was received stating "both trocars were unable to penetrate through the fascia so the trocar could enter into the peritoneal cavity." additional information was received via email on 17nov2023 from litigation counsel, applied medical: applied¿s legal department received a letter from a law firm on (b)(6) 2023, alleging that patient injuries were associated with a salpingectomy procedure on (b)(6) 2022, which utilized 2 #ctf01 trocars (l/n: 1428690).The procedure took place at [hospital name] in [state].Intervention: replaced with a new one to complete the case.Patient status: n/a, discharged.Patient injuries were associated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured obturator.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured obturator.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is to follow-up medwatch # mw5158251.
Event or Problem Description
Procedure performed: lap bilateral salpingectomy.Event description: complaint 1 of 2: (b)(4) (mfr report # 2027111-2023-00533).Complaint 2 of 2: (b)(4) (mfr report # 2027111-2023-00534).Two similar events occurred at the same facility during the same procedure."when trying to insert trocar into palmers point, trocar fractured.Another trocar was utilized, again trocar fractured into pieces.Both trocars were unable to a third trocar, was utilized and successfully entered the pt.Abdominal cavity." additional information was received via email on 24jul2023 from an applied medical representative: the break occurred at the obturator & tip.The hospital was not sure if there was any difficulty noted during the insertion of the device.The break was not considered to be clean as it was cracked/fractured and caused particulation.When asked if all the fragments were retrieved the hospital stated they were "unable to find within the incision sight." n/a noted for patient injury and the patient was discharged.The procedure was a lap bilateral salpingectomy.Clarification on the initial event description was received stating "both trocars were unable to penetrate through the fascia so the trocar could enter into the peritoneal cavity." additional information was received via email on 17nov2023 from litigation counsel, applied medical: applied¿s legal department received a letter from a law firm on november 14, 2023, alleging that patient injuries were associated with a salpingectomy procedure on (b)(6) 2022, which utilized 2 #ctf01 trocars (l/n: 1428690).The procedure took place at [hospital name] in [state].Medwatch associated with this complaint was received via email on 29aug2024 under the name of mw5158251: a 38 years old female admitted on 11/17 for elective tubal ligation.During the procedure, it was discovered that the trocar introducer tip was broken in two pieces.A defective trocar transducer tip, resulting in a retained piece of plastic, complicated surgery.This complication of retained foreign body led to severe sepsis shock requiring vasopressor support in order to stabilize her cardiovascular status and multiple abdominal surgeries/washouts.Patient was in a medically induced coma for two weeks and then woke up unable to move any of her extremities on (b)(6) 2023, nearly at baseline but with residual rhb (recombinant hemoglobin) weakness.Patient had a full neurological work-up due to dizziness and r side weakness most likely causes by frontal infarcts and deconditioning.Since the patient was requiring vasopressin support had led to the patient having ischemic necrosis of the right 3rd, 4th, 5th phalanges.The hospital course was prolonged and complicated by bacteremia, abdominal abscess, abdominal wound infection, right external iliac and right common femoral veins dvt (deep vein thrombosis), occlusion of the distal right radial artery, and cerebral frontal infarct.Since the patient was requiring vasopressin support, had led to the patient having ischemic necrosis of the right 3rd, 4th, and 5th phalanges.On (b)(6) 2023, the patient's areas of dry necrosis had demarcated on the right 3rd, 4th, and 5th phalanges pt.To proceed with operative management to resect the necrosis and revise the amputation site at the thumb, index, and middle fingers of the right hand.Pt hospital admission was from (b)(6) 2022-(b)(6) 2023, rehab admission from (b)(6) 2023-(b)(6) 2023.Intervention: replaced with a new one to complete the case.Patient status: n/a, discharged.Patient injuries were associated.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17410185
• Report Number: 2027111-2023-00533
• Device Sequence Number: 7121144
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)240928(30)01(10)1428690
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1428690
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023; Not provided
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 02/08/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White