MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB33
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 investigation.
Event or Problem Description
Procedure performed: laparoscopic sterilization.Event description: the product was opened before the procedure started and upon inspection by the surgeon before usage she saw that the blade did not want to retract.It was not used during the procedure and was not in contact with any bodily fluids or the patient.No one was hurt during the procedure.Patient status: was not in contact with any bodily fluids or the patient.
Additional 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 current 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.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit and further examination of the event description, applied medical determined that this event was not reportable as it is unlikely to cause or contribute to death or serious injury.G3: the date has been corrected from (b)(6) 2021 to (b)(6), 2021.
Event or Problem Description
Procedure performed: laparoscopic sterilization.Event description: the product was opened before the procedure started and upon inspection by the surgeon before usage she saw that the blade did not want to retract.It was not used during the procedure and was not in contact with any bodily fluids or the patient.No one was hurt during the procedure.Patient status: was not in contact with any bodily fluids or the patient.

• Brand Name: CTB33, 11X100 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: 11667545
• Report Number: 2027111-2021-00452
• Device Sequence Number: 11534324
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)230703(30)01(10)1386896
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 07/03/2023
• Device Model Number: CTB33
• Device Catalogue Number: 101472323
• Device Lot Number: 1386896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1