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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
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 could not be confirmed or replicated.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments 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." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: unknown.Event description: the event date is unknown."noticed black and clear plastic missing from inside trocar after use." patient status: no patient injury reported.
Event or Problem Description
Procedure performed: unknown.Event description: "noticed black and clear plastic missing from inside trocar after use." received mw5084976 via mail on 05apr2019 from the fda: event date: (b)(6) 2018"pt undergoing removal of lap band and port when scrub tech noticed black plastic and clear plastic from the inside of the trocar was damaged and missing.Dr.Verified no pieces left in pt.Surgeon:" additional information was received via email on 17apr2019 from risk management: "the medwatch report #mw5084976 and [hospital case] #50957147 are both about the same item.(ref (b)(4) item 1331891)." type of intervention: "dr.Verified no pieces left in pt." patient status: "no adverse event.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with the shield, a clear plastic component of the seal.Visual inspection of the event unit confirmed the complainant's experience of seal component separation.The shield and septum, a rubber component of the seal, were damaged and torn.Based on the condition of the returned unit, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments 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." this report is to follow-up medwatch report # mw 5084976.Correction to d2: change to "laparoscope, general & plastic surgery".
Additional Manufacturer Narrative
This report is to follow up medwatch #mw5084976.
Event or Problem Description
Procedure performed: unknown.Event description: "noticed black and clear plastic missing from inside trocar after use." received mw5084976 via mail on 05apr2019 from the fda: event date: (b)(6) 2018 "pt undergoing removal of lap band and port when scrub tech noticed black plastic and clear plastic from the inside of the trocar was damaged and missing.Dr.Verified no pieces left in pt.Surgeon:" additional information was received via email on 17apr2019 from risk management: "the medwatch report #mw5084976 and [hospital case] #50957147 are both about the same item.(ref cor37, item 1331891)." type of intervention: "dr.Verified no pieces left in pt." patient status: "no adverse event.".

• 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: 8380281
• Report Number: 2027111-2019-00367
• Device Sequence Number: 239754
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)210719(30)01(10)1331891
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/20/2019

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: 07/19/2021
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1331891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019; 02/20/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/01/2019; 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1