MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8701
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown laparoscopic surgery.Event description: a piece of a black plastic part of the seal fell into the patient.The piece was retrieved.The surgeon was using a grasper at the time the incident was noted.The safety officer at the hospital stated that a report was sent to the fda.Limited information was available at the time of reporting.The model and lot number is unknown.The procedure is unknown.The device is available for return.Additional information was received via email on 05dec2019 from clinical coordin: a piece of the trocar was torn apart.Additional information received via mail on 23dec2019 from fda medwatch program: report# mw5091514.Reporter: [name] risk manager event date: 25-nov-2019 event report type: serious injury event outcome: required intervention model: c8701 lot# 1369677 event description: the alexis laparoscopic system with kii fios first entry had a rubber piece break off and was inside the patient.Surgeon was able to retrieve rubber piece from torcher within set.Fda safety report id # (b)(4).Patient status: no patient injury occurred as a result of the complaint event.
Event or Problem Description
Procedure performed: unknown laparoscopic surgery.Event description: a piece of a black plastic part of the seal fell into the patient.The piece was retrieved.The surgeon was using a grasper at the time the incident was noted.The safety officer at the hospital stated that a report was sent to the fda.Limited information was available at the time of reporting.The model and lot number is unknown.The procedure is unknown.The device is available for return.Additional information was received via email on 05dec2019 from clinical coordin: a piece of the trocar was torn apart.Additional information received via mail on 23dec2019 from fda medwatch program: report# mw5091514.Reporter: [name] risk manager: event date: (b)(6) 2019.Event report type: serious injury.Event outcome: required intervention.Model: c8701.Lot# 1369677.Event description: the alexis laparoscopic system with kii fios first entry had a rubber piece break off and was inside the patient.Surgeon was able to retrieve rubber piece from torcher within set.Fda safety report id # (b)(4).Patient status: no patient injury occurred as a result of the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a rubber component.Visual inspection of the event unit confirmed the complainant¿s experience of seal component separation.The rubber fragment completed the missing portion on the septum, a rubber component of the seal.The duckbill, another 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 non-axial insertion or removal of asymmetrical instruments, such as the grasper, 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." this event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report #mw5091514.

• Brand Name: C8701, S ALEXIS LAP SYS W/KII FIOS 5/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: 9593690
• Report Number: 2027111-2020-00319
• Device Sequence Number: 3244927
• Product Code: GCJ
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)220929(30)01(10)1369677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 09/29/2022
• Device Model Number: C8701
• Device Catalogue Number: 101473672
• Device Lot Number: 1369677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/05/2020
• 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: GRASPER