MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR34, 11X100 KII OPT ZTHR HDL 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR34
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 procedures.Event description: (b)(4).Date of event: (b)(6).The surgeon use the optical tecnic for the firt acces in laparoscopic procedures.During 2 different procedures the opturator of the trocar is too small to house the laparoscope.The surgeon inform that the 5 trocars had the same problem, but she don't remember the model and the lot of this trocars.Additional information received by email from applied medical representative on (b)(6) 2022: model ctr34 lot 1424056.Additional information received by email from applied medical representative on (b)(6) 2022: brand of laparoscope: [brand name] model of the laparoscope: 30° optics size: 10mm additional information received by email from applied medical representative on (b)(6) 2022: the user experienced inconsistent resistance during instrument manipulation.Patient status: no patient injury has been reported.
Event or Problem Description
Procedure performed: laparoscopic procedures.Event description: event 1 of 5: (b)(4) (mfr report 2027111-2022-00679); event 2 of 5: (b)(4) (mfr report 2027111-2022-00680); event 3 of 5: (b)(4) (mfr report 2027111-2022-00681); event 4 of 5: (b)(4) (mfr report 2027111-2022-00682); event 5 of 5: (b)(4) (mfr report 2027111-2022-00683).Date of event: 30-31/05/2022.The surgeon use the optical tecnic for the firt acces in laparoscopic procedures.During 2 different procedures the opturator of the trocar is too small to house the laparoscope.The surgeon inform that the 5 trocars had the same problem, but she don't remember the model and the lot of this trocars.Additional information received by email from applied medical representative on 15june22: model ctr34 lot 1424056.Additional information received by email from applied medical representative on 1july2022: brand of laparoscope: [brand name] model of the laparoscope: 30° optics size: 10mm additional information received by email from applied medical representative on 12july2022: the user experienced inconsistent resistance during instrument manipulation.Patient status: no patient injury has been reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of improper fit.Upon closer inspection, the obturator was observed to have a misaligned feature inside the obturator.Based on the condition of the returned unit, the reported event was caused by the misaligned feature, caused by a molding defect.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.Correction: updated section h6 component codes to 887 - mount.

• Brand Name: CTR34, 11X100 KII OPT ZTHR HDL 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: 15153952
• Report Number: 2027111-2022-00682
• Device Sequence Number: 5268030
• Product Code: GCJ
• UDI-Device Identifier: 00607915124243
• UDI-Public: (01)00607915124243(17)240920(30)01(10)1424056
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 09/20/2024
• Device Model Number: CTR34
• Device Catalogue Number: 101470935
• Device Lot Number: 1424056
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: [BRAND NAME] LAPAROSCOPE
• Patient Sex: Unknown