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

Model Number CTB03

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Procedure performed: appendectomy.Event description: two complaints have been made from this submission.The quality assurance coordinator describes as an action not satisfactory as follow : 'two trocars are opened for surgery, the surgeon, when trying to occupy supplies, comments that the first trocar has no edge, the second trocar is delivered and repeats the same product available for return.Additional information received via email on (b)(60 2022 from applied medical representative: confirm that the patient had no problem.Additional information received via email on (b)(6) 2022 from applied medical representative: the complaint the facility submitted is that the blade was dull.Patient status: confirm that the patient had no problem.

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.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit.However, the complainant¿s experience could not be replicated or confirmed as the returned unit performed as intended.The returned unit met specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event 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.

Event Description

Procedure performed: appendectomy.Event description: two complaints have been made from this submission.Complaint # (b)(4) [mfr report # 2027111 - 2022 - 00458].Complaint # (b)(4) [mfr report # 2027111 - 2022 - 00459]."the quality assurance coordinator describes as an action not satisfactory as follow: two trocars are opened for surgery, the surgeon, when trying to occupy supplies, comments that the first trocar has no edge, the second trocar is delivered and repeats the same." product available for return.Additional information received via email on 02mar2022 from applied medical representative: "confirm that the patient had no problem." additional information received via email on 07mar2022 from applied medical representative: the complaint the facility submitted is that the blade was dull.Patient status: confirm that the patient had no problem.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13712882
• MDR Text Key: 293627901
• Report Number: 2027111-2022-00459
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)240609(30)01(10)1417367
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K072674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1417367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1