MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF05, 5X75 KII FIOS ADV FIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF05
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
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: ladg.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.Detachment of the septum.Report from the sales rep.The septum was detached from seal component during the procedure.The fragment was recovered from the body cavity.The case was completed with the new one.Initial investigation report the event unit was returned to us and visually inspected.The septum was detached from the seal component.It was fragmented.The returned fragment is similar to the missing section on the septum in shape.The unit will be returned to amr for further evaluation.The type of procedure was upper gs surgery, ladg.The operation time was 3-5 hours.The surgeon's skill level was mid-career.The main usage of the damaged trocar was as the 2nd port.[non-applied] energy device, grasper, scissors and gauze were inserted/removed into/from the damaged trocar.The number of insertion/removal was 10-30 times.The damage was found after the case.The surgeon(s) and or nurse(s) found the damage by finding the parts during the case.Felt something stuck.After the damage was found, removed all damaged parts.Intraperitoneal irrigation was performed.This is the first time this issue has happened at the same department/specialty at the hospital.Intervention: the case was completed with the new one.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 a piece of the septum, an internal rubber component of the seal, had separated from the seal.The rubber fragment completed the missing portion on the septum.Engineering also observed that the shield, an internal plastic component of the seal, had also 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 and/or material 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." septum fragmentation is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.However, the event is reportable due to the dislodged shield.
Event or Problem Description
Procedure performed: ladg.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.Detachment of the septum.Report from the sales rep the septum was detached from seal component during the procedure.The fragment was recovered from the body cavity.The case was completed with the new one.Initial investigation report the event unit was returned to us and visually inspected.The septum was detached from the seal component.It was fragmented.The returned fragment is similar to the missing section on the septum in shape.The unit will be returned to amr for further evaluation.The type of procedure was upper gs surgery, ladg.The operation time was 3-5 hours.The surgeon's skill level was mid-career.The main usage of the damaged trocar was as the 2nd port.[non-applied] energy device, grasper, scissors and gauze were inserted/removed into/from the damaged trocar.The number of insertion/removal was 10-30 times.The damage was found after the case.The surgeon(s) and or nurse(s) found the damage by finding the parts during the case.Felt something stuck.After the damage was found, removed all damaged parts.Intraperitoneal irrigation was performed.This is the first time this issue has happened at the same department/specialty at the hospital.Intervention: the case was completed with the new one.Patient status: no patient injury.

• Brand Name: CFF05, 5X75 KII FIOS ADV FIX 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: 10174740
• Report Number: 2027111-2020-00486
• Device Sequence Number: 11419438
• Product Code: GCJ
• UDI-Device Identifier: 00607915123123
• UDI-Public: (01)00607915123123(17)221107(30)01(10)1373105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: CFF05
• Device Catalogue Number: 101220801
• Device Lot Number: 1373105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: HD1000I ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE.; HD1000I ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE.