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

Model Number	CTB03
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
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.Event description: for the second trocar, the blade of the introducer appeared too dull to cut through tissue safely toe enter the patient.Packaging included for second trocar in case that was the issue and not the introducer.Product is available for return.Additional information received via email on 18jun2021 from [user facility]: the blade dullness was first noted, "when dr.[name] tried to put in the second trocar.After three attempts she asked for a new trocar and to do the non-conforming product paperwork on the one that appeared dull.Note that it was a different trocar than what came with the introducer." the dull introducer came from a different trocar than the one that was being inserted into the patient at the time of the event.The trocar being inserted was a cts02, the lot number is unknown.The case was completed by using another ctb03.Intervention: the case was completed by using another ctb03.Patient status: patient not affected.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a dull blade, the tip of the blade was damaged.Based on the condition of the returned unit and the description of the event, it is likely that the blade was damaged during the procedure, prior to the second insertion, as no malfunction was reported with the first insertion using the blade.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: for the second trocar, the blade of the introducer appeared too dull to cut through tissue safely to enter the patient.Packaging included for second trocar in case that was the issue and not the introducer.Product is available for return.Additional information received via email on (b)(6) 2021 from [user facility]: the blade dullness was first noted, "when dr.[name] tried to put in the second trocar.After three attempts she asked for a new trocar and to do the non-conforming product paperwork on the one that appeared dull.Note that it was a different trocar than what came with the introducer." the dull introducer came from a different trocar than the one that was being inserted into the patient at the time of the event.The trocar being inserted was a cts02, the lot number is unknown.The case was completed by using another ctb03.Additional information received via email on (b)(6) 2021 from [user facility]: yes the obturator/introducer was successfully used during the first insertion during the case.Intervention: the case was completed by using another ctb03.Patient status: patient not affected.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/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: 12104250
• Report Number: 2027111-2021-00555
• Device Sequence Number: 19883577
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)240328(30)01(10)1411358
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 03/28/2024
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1411358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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: CTS02