MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB73
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	03/25/2022
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 the investigation.
Event or Problem Description
Procedure performed: right laparoscopic colectomy.Event description: [translation]: when inserting a laparo device into the adapted trocar, a piece of rubber from the membrane got broken and fell (by chance in the operator's field of vision) into the patient's abdominal cavity and could have been unseen and left in the abdomen.Additional information received by email from applied medical representative on (b)(6) 2022.Name of procedure being performed: right laparoscopic colectomy.Patient status : nothing to report due to the immediate reaction of the team.Pieces fell into the patient and were all retrieved from the patient.The inner membrane detached from the seal.The component was black.The entire component appeared to be torn off.Self-suturing pliers diam 12 were being used at the time of the incident.Type of intervention: pieces fell into the patient and were all retrieved from the patient.Patient status: nothing to report due to the immediate reaction of the team.
Additional Manufacturer Narrative
A portion of the event unit was returned to applied medical for evaluation, along with a black fragment.Visual inspection of the event unit confirmed the complainant¿s experience of seal component separation.The black fragment matched the missing portion of the septum, an internal rubber component of the seal.Based on the condition of the returned unit, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states, "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." this event was initially reported based on the description of the event.However, based on the evaluation of the event unit and additional information, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: right laparoscopic colectomy.Event description: [translation]: when inserting a laparo device into the adapted trocar, a piece of rubber from the membrane got broken and fell (by chance in the operator's field of vision) into the patient's abdominal cavity and could have been unseen and left in the abdomen.Additional information received by email from applied medical representative on 13apr22: name of procedure being performed: right laparoscopic colectomy.Patient status : nothing to report due to the immediate reaction of the team.Pieces fell into the patient and were all retrieved from the patient.The inner membrane detached from the seal.The component was black.The entire component appeared to be torn off.Self-suturing pliers diam 12 were being used at the time of the incident.Additional information received by email from applied medical representative on 16june22: as discussed by phone, based on the device returned and initial description of the incident the customer experience a seal component fragmentation and not a seal component dislodgment.Type of intervention: pieces fell into the patient and were all retrieved from the patient.Patient status: nothing to report due to the immediate reaction of the team.

• Brand Name: CTB73, 12X100 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: 14312121
• Report Number: 2027111-2022-00589
• Device Sequence Number: 17399986
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)240310(30)01(10)1408624
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 03/10/2024
• Device Model Number: CTB73
• Device Catalogue Number: 101472289
• Device Lot Number: 1408624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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: SELF-SUTURING PLIERS DIAM 12
• Patient Sex: Prefer Not To Disclose