MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q19, KII 8X100 Z-THR OPT SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0Q19
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	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience of seal component separation could not be replicated or confirmed.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrumentation (needle) 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.".
Event or Problem Description
Procedure performed: lap sacrocolpopexy.Event description: rep was not present for the case.[name] was performing a lap sacrocolpopexy.He said they noticed that the entire clear shield had come out and was inside the patient.The shield was retrieved and grabbed another trocar to finish the case.[name] thought that he snagged the seal going back and forth with the needle.The needle was passed back and forth around 15 times.There was no patient injury.The trocar was discarded after the case.Type of intervention: replaced with a new trocar.Patient status: no patient injury.
Additional Manufacturer Narrative
This report is to follow up medwatch report #mw5093044.
Event or Problem Description
Procedure performed: lap sacrocolpopexy.Event description: rep was not present for the case.[name] was performing a lap sacrocolpopexy.He said they noticed that the entire clear shield had come out and was inside the patient.The shield was retrieved and grabbed another trocar to finish the case.[name] thought that he snagged the seal going back and forth with the needle.The needle was passed back and forth around 15 times.There was no patient injury.The trocar was discarded after the case.Additional information was received from fda medwatch, mw# 5093044, via mail on march 2nd, 2020: event description: "plastic inside of trocar broke off and was found in abdomen during procedure.The piece was removed from abdomen immediately.Trocar was inspected, removed from the pt and replaced with a new one.Procedures: laparoscopic sacral colpopexy with cystoscopy.Op.Note: "in the left lower quadrant, an 8 mm and a 5 mm trocar were placed.We later replaced the 8 mm with the 11 mm trocar." fda safety report id# (b)(4)." type of intervention: replaced with a new trocar patient status: no patient injury.

• Brand Name: C0Q19, KII 8X100 Z-THR OPT SYS 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: 9772149
• Report Number: 2027111-2020-00397
• Device Sequence Number: 16290263
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)221118(30)01(10)1374783
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 11/18/2022
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1374783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE