MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB33, 11X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2021
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 the investigation.
Event or Problem Description
Procedure performed: lap oophorectomy.Event description: transcription of telephone conversation with [name] at [hospital] 27jul21: event involving cfb33 lot 1405933, exp 14-03-2024, occurred yesterday afternoon.During use, tip of cannula broke, small fragments in the abdomen.All pieces could not be recovered, some were removed but not all.Procedure was a lap oophorectomy.Product is available: return can be arranged.Intervention: surgeon attempted to retrieve fragments - some were removed, could not retrieve all pieces.Patient status: unintended material left behind in patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with green fragments.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip, and the fragments were identified to be part of the cannula tip.Based on the condition of the returned unit, it is possible that the cannula tip fractured due a large force applied to the cannula tip.It is also possible that the cannula was more susceptible to breakage.However, the exact root cause of the cannula tip fracture is unknown.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: lap oophorectomy/salpingectomy.Event description: transcription of telephone conversation with [name] at [hospital] (b)(6) 2021: event involving cfb33 lot 1405933, exp 14-03-2024, occurred yesterday afternoon.During use, tip of cannula broke, small fragments in the abdomen.All pieces could not be recovered, some were removed but not all.Procedure was a lap oophorectomy.Product is available ¿ return can be arranged.Additional information from mhra incident report received via email 10aug21: incident happened during a laparoscopic salpingectomy.The tip of one of the single use cannulas used to gain access to the abdomen appeared to have broken and fragments of plastic were noticed in the abdominal cavity.The patient does not appear to have suffered any harm.The operating surgeon managed to retrieve all visible broken fragments from abdominal cavity with forceps.The surgeon irrigated and suctioned the abdominal cavity in the hope of collecting more fragments but during the procedure the anaesthetic consultant was concerned as the patient did not tolerate the patient's position well or the insufflation of co2 gas required to aid the procedure.The surgeon deemed it was safest to complete the surgery in the best interest of the patient.All fragments found were collected and kept together with the broken cannula.At the end of the procedure the suction canisters were emptied and examined.When all retrieved fragments were examined it was noted that there is discrepancy between found and missing fragments.When awake, patient was informed by the gynaecology consultant that more fragments may remain in her abdomen; however patient declined further investigation for this.This discussion was documented in the patient's notes.Nurse in charge was informed an e-incident was generated and the incident was documented in nursing notes.(this item is not radiopaque therefore an x-ray was not done).Intervention: surgeon attempted to retrieve fragments - some were removed, could not retrieve all pieces.Patient status: unintended material left behind in patient.

• Brand Name: CFB33, 11X100 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
• MDR Report Key: 12304984
• Report Number: 2027111-2021-00601
• Device Sequence Number: 3612683
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)240314(30)01(10)1405933
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 03/14/2024
• Device Model Number: CFB33
• Device Catalogue Number: 101473821
• Device Lot Number: 1405933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1