MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR03
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
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.This report is to follow-up uf/importer report # 0504240000-2022-8021.
Event or Problem Description
Procedure performed: unknown.Event description: while introducing trocar into patients abdominal wall trocar bent while applying expected pressure to trocar & obturator, reached patient but no injury product is available for return.Patient status: no injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged trocar as the cannula was bent.The wall thickness of the cannula and obturator were measured and met specifications.Based on the condition of the returned unit and similar previous incidents, it is likely that the reported event was caused by a high force exerted on the unit during insertion.It is possible that the physical characteristics of the patient contributed to the force exerted on the unit during insertion.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: unknown.Event description: "while introducing trocar into patients abdominal wall trocar bent while applying expected pressure to trocar & obturator, reached patient but no injury" product is available for return.Patient status: no injury.

• Brand Name: CTR03, 5X100 KII OPT 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14606853
• Report Number: 2027111-2022-00622
• Device Sequence Number: 5001157
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)250202(30)01(10)1441066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 02/02/2025
• Device Model Number: CTR03
• Device Catalogue Number: 101138201
• Device Lot Number: 1441066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Unknown