MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; GCJ

Model Number	C0R37
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "laparoscopic gastric sleeve" event description: cer 1 of 2: (b)(4), cer 2 of 2: (b)(4)."happened in both first case and second case.Part of the seal fell off in the patient and they had to go retrieve it.Happened in the middle of the case.The surgeon was using the trocar." type of intervention: "procedure completed with new trocar" patient status: "they couldn't state anything about potential future complications, but nothing was wrong then.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, nine (9) sterile units were returned for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.The sterile units were visually inspected and no non-conformances were observed.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 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.This report is to follow up medwatch report #mw#5074110.
Event or Problem Description
Additional information was received via email, from sales associate on tuesday 2-jan-2018: "materials said he sent back all items, so if they aren't in the box they must have disposed of them." additional information was received via mail, from fda medwatch #mw5074110 on 11jan2018: "applied medical kii optical access system: trocar was inserted into patient.Surgeon was using []clip appliers and seal of trocar broke off into patient's abdomen.Surgeon retrieved the seal.No adverse impact to the patient.Diagnosis or reason for use: surgery.Event abated after use stopped or dose reduced: yes.".

• Brand Name: C0R37, 15X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7143516
• Report Number: 2027111-2017-02160
• Device Sequence Number: 13730479
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)201005(30)01(10)1307303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/26/2018

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: Other
• Device Expiration Date: 10/05/2020
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1307303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1