MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTB03

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Date of death: ni.Procedure performed: unknown.Event description: the matron told me on wed (b)(6) 2021 at (b)(6) hospital that a patient passed away because of an applied trocar that was used on him/her.While i was busy uplifting a ctb03 from her she said that a patient died from this trocar in 2020.She did not give any specifics about the event, the date, time, doctor or patient.Neither did she mention the item codes of the trocar that was used during the time.We do not know if it was a ctb03 or ctb33.Patient status: patient death.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, an analysis of the event unit could not be performed and engineering was unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Based on the event description and previous complaints received from the facility, it is unlikely that a product malfunction occurred as event units from previous complaints of shield deactivation were evaluated and no non-conformances were observed.The surgeon also stated that "he doesn't think the trocar was the cause of death".

Event Description

Date of death: ni.Procedure performed: unknown.Event description: the matron told me on wed (b)(6) 2021 at day hospital that a patient passed away because of an applied trocar that was used on him/her.While i was busy uplifting a ctb03 from her she said that a patient died from this trocar in 2020.She did not give any specifics about the event, the date, time, doctor or patient.Neither did she mention the item codes of the trocar that was used during the time.We do not know if it was a ctb03 or ctb33.Additional information provided by distributor via email 19mar21: i saw [name] regarding the product failure where the patient died and received the below information: product code: ctb03.It was a secondary trocar insertion under vision.[surgeon] said that he is struggling lately with our ctb03 trocars.He said that the safety shield is deactivating the whole time.During this incident he did reactivate the blade again and the next moment there was just blood.The bleeding came from a vein ¿ he couldn't tell me which one.They controlled the bleeding and the patient was transferred to [another] hospital.The patient collapsed in casualties and were transferred to icu.That evening the patient was taken to theatre again where a surgeon assisted.There were only between 300 ¿ 500 ml blood in the abdomen.There was no more active bleeding.The next morning the patient passed away.He said that the patient's spouse told him that the patient had heart problems and could be the cause of everything and their body couldn't handle the operation.[surgeon] is still using our trocars even after the incident.He said that he is not struggling with our primary trocar insertion with the ctb33¿s.A suggestion was made to evaluate the optical/bladeless 5mm trocar for his secondary insertion for his next laparoscopy.He said that he doesn't think the trocar was the cause of death.Additional information provided by distributor via email 13apr21: the insertion method used was continuous force.There was no audible click before having to reactivate the blade.Patient status: patient death.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11345585
• MDR Text Key: 232505318
• Report Number: 2027111-2021-00340
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K072674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CTB03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death