MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF12, 5X100 KII FIOS ADVFIX DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
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 investigation.
Event or Problem Description
Procedure performed: lap endometriosis.Event description: spot coagulation with sharp tipped [] bipolair electrode.Seal protection was punctured and ended up in the patients abdomen.Was also removed after discovery.Puncture of the seal protection was concluded post procedure when seal housing was taken apart to investigate.Additional information received from team member by email on 06mar2020: it was the entire instrument shield that separated from the seal housing.Intervention: retrieval of separated part.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal and was damaged.Engineering also observed that the septum, an internal rubber component of the seal, was torn.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an asymmetrical instrument (bipolar electrode) that was inserted through the seal subassembly in a non-axial manner.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: lap endometriosis.Event description: spot coagulation with sharp tipped [] bipolair electrode.Seal protection was punctured and ended up in the patients abdomen.Was also removed after discovery.Puncture of the seal protection was concluded post procedure when seal housing was taken apart to investigate.Additional information received from team member by email on 06mar2020: it was the entire instrument shield that separated from the seal housing.Intervention: retrieval of separated part.Patient status: no patient injury.

• Brand Name: CFF12, 5X100 KII FIOS ADVFIX DP 10/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: 9829989
• Report Number: 2027111-2020-00416
• Device Sequence Number: 727622
• Product Code: GCJ
• UDI-Device Identifier: 00607915124090
• UDI-Public: (01)00607915124090(17)221107(30)01(10)1373098
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 11/07/2022
• Device Model Number: CFF12
• Device Catalogue Number: 101452601
• Device Lot Number: 1373098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BISSINGER BIPOLAR ELECTRODE; BISSINGER BIPOLAR ELECTRODE