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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap kystectomie / lap cystectomy.Event description: the nurse reported that when the surgeon inserted a johann forceps with an [non-applied retrieval bag], it was first more difficult than usual ; one of the black seal and the white one from our trocar were separated from the trocar itself, felt out of the trocar in the abdominal cavity, but not free as they were around the cord of this [non-applied retrieval bag].Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with a black fragment.Visual inspection confirmed the complainant's experience of seal component separation, as the shield, a clear plastic internal component of the seal, had separated from the seal.The black fragment completed the missing portion on the septum, a rubber component of 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 instrumentation through the trocar.Applied medical¿s instructions for use 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 kystectomie / lap cystectomy.Event description: the nurse reported that when the surgeon inserted a johann forceps with an [non-applied retrieval bag], it was first more difficult than usual ; one of the black seal and the white one from our trocar were separated from the trocar itself, felt out of the trocar in the abdominal cavity, but not free as they were around the cord of this [non-applied retrieval bag].Patient status: no patient injury.

• 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: 8827711
• Report Number: 2027111-2019-00529
• Device Sequence Number: 14037732
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)220225(30)01(10)1349801
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: 02/25/2022
• Device Model Number: CFB33
• Device Catalogue Number: 101246001
• Device Lot Number: 1349801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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: ESPINER TISSUE RETRIEVAL SYSTEM, REF EMP100ECO-S