MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R37
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
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.This report is to follow-up medwatch #(b)(4).
Event or Problem Description
Procedure performed: pancreatectomy distal and splenectomy - laparoscopic robotic assisted.Event description: medwatch #(b)(6) received via mail on 04jun2019.During xi robotic laparoscopic case, black piece (approx.1/4 inch) fell off trocar and was found in abdomen of patient.Piece removed.Date of event: (b)(6) 2019.Additional information received via email on 06jun2019 from user facility: there was no patient injury.There was no harm to patient.Date of the event was (b)(6) 2019.The part of the seal that detached is unknown.It is unknown if the entire component fell out or was torn off.It is unknown what instrumentation was being used at the time of the incident.The device is available for return.Additional information received via email on 06jun2019 from user facility: yes, i have the device.It is not the full trocar, but rather a piece of it.Additional information received via email on 10jun2019 from user facility: i don't have the copy of the fmd, but believe it was the 15mm trocar.The information below is for the c0r37.The date of the case was (b)(6) 2019.The procedure was being performed was a xi pancreatectomy distal and splenectomy- laparoscopic robotic assisted.When the fragment of the trocar entered the body, a stapler was being passed through the trocar.The lot number of the trocar is 1335513."failed medical device form received: during laparoscopic case, black plastic piece (approx.1/4 inch) fell off trocar and was found in abdomen per surgeon.Piece was removed." type of intervention: piece removed.Patient status: there was no harm to patient.
Event or Problem Description
Procedure performed: pancreatectomy distal and splenectomy - laparoscopic robotic assisted.Event description: medwatch #2600320000-2019-8057 received via mail on 04jun2019.During xi robotic laparoscopic case, black piece (approx.1/4 inch) fell off trocar and was found in abdomen of patient.Piece removed.Date of event: (b)(6) 2019.Additional information received via email on 06jun2019 from user facility: there was no patient injury.There was no harm to patient.Date of the event was (b)(6) 2019.The part of the seal that detached is unknown.It is unknown if the entire component fell out or was torn off.It is unknown what instrumentation was being used at the time of the incident.The device is available for return.Additional information received via email on 06jun2019 from user facility: yes, i have the device.It is not the full trocar, but rather a piece of it.Additional information received via email on 10jun2019 from user facility: i don't have the copy of the fmd, but believe it was the 15mm trocar.The information below is for the c0r37.The date of the case was (b)(6) 2019.The procedure was being performed was a xi pancreatectomy distal and splenectomy- laparoscopic robotic assisted.When the fragment of the trocar entered the body, a stapler was being passed through the trocar.The lot number of the trocar is 1335513."failed medical device form received: during laparoscopic case, black plastic piece (approx.1/4 inch) fell off trocar and was found in abdomen per surgeon.Piece was removed." type of intervention: piece removed.Patient status: there was no harm to patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a rubber fragment.Visual inspection 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.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 stapler, 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 # 2600320000-2019-8057.

• Brand Name: C0R37, 15X100 KII OPT ZTHR 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: 8696435
• Report Number: 2027111-2019-00476
• Device Sequence Number: 14022108
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)210830(30)01(10)1335513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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): 07/24/2019

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: 08/30/2021
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1335513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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: ROBOT, STAPLER
• Patient Age: 67 YR