MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB73, 12X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB73
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: intestinal (transversum) resection.Event description: information received via email on (b)(6) 2021 from applied medical representative: just received a call from customer reporting a cfb73 that "lost" the transparent membrane during surgery.The membrane was detected in the abdomen by accident, customer assumes it remained in the abdomen when removing the trocar.Information received from complaint form via email from applied medical representative on 01dec2021: the trocar was used for laparoscopic access during a transversum resection.The incident occurred during insertion of a 10mm retrieval bag through the trocar.After inserting the 10 mm retrieval bag through the trocar, it was noticed that the stick of the retrieval bag was harder to remove through the trocar and stuck to the seal.A clear plastic part of the seal was then found in the abdomen, which had come loose.To retrieve the part, it was cut in half.It was then found that this part was missing from the trocar.According to the or-staff, all tools were used according to the rules and no pressure was exerted on the trocar.There were no changes in health.Because it happened nearly at the end of the procedure there was no replacement or change necessary.A 10mm retrieval bag was in use as well.Type of intervention: because it happened nearly at the end of the procedure there was no replacement or change necessary.Patient status: no patient injury.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments (such as the stick of the retrieval bag) through the trocar.Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".
Event or Problem Description
Procedure performed: intestinal (transversum) resection.Event description: information received via email on (b)(6) 2021 from applied medical representative: just received a call from customer reporting a cfb73 that "lost" the transparent membrane during surgery.The membrane was detected in the abdomen by accident, customer assumes it remained in the abdomen when removing the trocar.Information received from complaint form via email from applied medical representative on (b)(6) 2021: the trocar was used for laparoscopic access during a transversum resection.The incident occurred during insertion of a 10mm retrieval bag through the trocar.After inserting the 10 mm retrieval bag through the trocar, it was noticed that the stick of the retrieval bag was harder to remove through the trocar and stuck to the seal.A clear plastic part of the seal was then found in the abdomen, which had come loose.To retrieve the part, it was cut in half.It was then found that this part was missing from the trocar.According to the or-staff, all tools were used according to the rules and no pressure was exerted on the trocar.There were no changes in health.Because it happened nearly at the end of the procedure there was no replacement or change necessary.A 10mm retrival bag was in use as well.Intervention: because it happened nearly at the end of the procedure there was no replacement or change necessary.Patient status: no patient injury.

• Brand Name: CFB73, 12X100 KII SH BLD ADVFIX 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: 12962834
• Report Number: 2027111-2021-00762
• Device Sequence Number: 1728463
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)240707(30)01(10)1415446
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083638
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 07/07/2024
• Device Model Number: CFB73
• Device Catalogue Number: 101473808
• Device Lot Number: 1415446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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: 10MM RETRIEVAL BAG.
• Patient Sex: Unknown