MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS12, 11X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	7
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
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.This report is to follow up medwatch report #mw5069962.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Medwatch description #mw5069962; "a piece of rubber from the trocar sleeve came off when a clip applier was passed through it." additional information received via email from the implementation specialist on (b)(6) 2017.A piece of rubber detached from the seal.Doctor performed the surgery.Type of intervention - unknown.Patient status - unknown.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.Based on the description of the event, 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.This report is to follow up medwatch report # mw5069962.
Event or Problem Description
Additional information received via the telephone at 8:35am from implementation specialist on (b)(4) 2017.The device was discarded by the facility and not available for return.No further information regarding the event is available.

• Brand Name: CTS12, 11X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6644196
• Report Number: 2027111-2017-01856
• Device Sequence Number: 849175
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)191108(30)01(10)1283148
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: 7
• 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): 08/11/2017

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: 11/08/2019
• Device Model Number: 7
• Device Catalogue Number: 7
• Device Lot Number: 1283148
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 08/11/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLIP APPLIER