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

Model Number	C0R37
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Lap gastric band - when inserting the gastric band through the trocar in to the patient, the team noticed that the inner black seal of the trocar was inside the patient and lodged over the gastric band.The surgeon replaced the port with another c0r37 and retrieved the seal from the patient.Type of intervention - "n/a".Patient status - no patient injury.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.The rubber fragment returned matched the missing portion on the seal.Engineering also noted that the shield, an internal component of the seal, was damaged and dislodged.The likely root cause of the damage to the seal is an instrument.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.
Event or Problem Description
Additional information received via email from team member on march 06, 2017: "the theatre sister has just informed me that there were 5 mm ports used during this procedure.However, she stated that no damage was observed to these units." (b)(4) was created in response to the extra shield received with the returned product from (b)(4).

• 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: 6311946
• Report Number: 2027111-2017-01392
• Device Sequence Number: 16343293
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)190712(30)01(10)1274725
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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: 07/12/2019
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1274725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1