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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: tamis: transanal minimal invasive procedure for removal of a rectal polyp.Event description: surgeon was performing a difficult lap chole case, there appeared to be no visible defect in the trocar from when it was opened from its packaging.Also the trocar performed as normal upon insertion into the abdomen.The resection of the gallbladder was completed but some gall stones did fall into the abdomen.As the surgeon was retrieving these stones the scrub nurse noticed at that point a fragment of plastic in the abdomen, upon inspection it was identified as a fragment of the 11x100mm trocar.There were a few small pieces inside the abdomen that required retrieval.Once the fragments were retrieved they were matched up outside the patients abdomen to confirm all pieces were collected.The surgeon & scrub nurse has never seen this happen before and both have over twenty years experience.No patient was not affected and the case was completed.Intervention: retrieval of separated parts.Patient status: recovering.
Additional 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.
Event or Problem Description
Procedure performed: tamis - transanal minimal invasive procedure for removal of a rectal polyp event description: surgeon was performing a diffcult lap chole case, there appeared to be no visible defect in the trocar from when it was opened from its packaging.Also the trocar performed as normal upon insertion into the abdomen.The resection of the gallbladder was completed but some gall stones did fall into the abdomen.As the surgeon was retrieving these stones the scrub nurse noticed at that point a fragemnt of plastic in the abdomen, upon inspection it was identified as a fragment of the 11x100mm trocar.There were a few small pieces inside the abdomen that required retrieval.Once the fragments were retrieved they were matched up outside the patients abdomen to confirm all pieces were collected.The surgeon & scrub nurse has never seen this happen before and both have over twenty years experience.No patient was not affected and the case was completed.Intervention: retrieval of separated parts patient status: recovering - patient was not affected and the case was completed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with one green fragment.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.The green fragment was identified to be a portion of the missing cannula tip.Based on the condition of the returned unit, it is possible that the cannula tip fractured due to a large force exerted on the cannula tip or an object or instrument coming in contact with the cannula tip during the procedure.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13955936
• Report Number: 2027111-2022-00535
• Device Sequence Number: 4782441
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)240524(30)01(10)1415100
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 05/24/2024
• Device Model Number: CTB33
• Device Catalogue Number: 101472323
• Device Lot Number: 1415100
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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: STANDARD MONOPOLAR HOOK. MEDTRONIC ENDOCLIPML11
• Patient Sex: Unknown