MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR22, 5X100 KII LP OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR22
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: "hair found in sterile packaging - did not reach patient, detected prior to procedure." additional information was received via email on 02may2021 from [name]: the correct lot number is reported as 1395785."the customer has the complaint sample but does not think it is cost effective to return.The customer would prefer to send an image of the complaint sample so that it can be discarded afterward." additional information was received via email on 03may2021 from [name]: photograph was provided.Patient status: not patient involvement.Type of intervention: na-detected prior to procedure.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on photograph of the event unit, the hair originated from an operator during the manufacturing process.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: "hair found in sterile packaging - did not reach patient, detected prior to procedure." additional information was received via email on 02may2021 from [name]: the correct lot number is reported as 1395785."the customer has the complaint sample but does not think it is cost effective to return.The customer would prefer to send an image of the complaint sample so that it can be discarded afterward." additional information was received via email on 03may2021 from [name]: photograph was provided.Patient status: not patient involvement.Type of intervention: na-detected prior to procedure.

• Brand Name: CTR22, 5X100 KII LP 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
• MDR Report Key: 12029107
• Report Number: 2027111-2021-00531
• Device Sequence Number: 3604600
• Product Code: GCJ
• UDI-Device Identifier: 00607915126506
• UDI-Public: (01)00607915126506(17)230909(30)01(10)1395785
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: No Information
• Device Expiration Date: 09/09/2023
• Device Model Number: CTR22
• Device Catalogue Number: 101179901
• Device Lot Number: 1395785
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1