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

Model Number	5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
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
Laparoscopic cholecystectomy - towards the end of the procedure the consultant noticed some of the black seal housing in the patient.He is unsure when the black rubber piece of the seal housing actually tore off.Other products used down this port, apart from the normal 5 mm instruments, was a [non-applied] clip applier with a purple clip.The seal housing is being kept for applied medical collection.The black portion of the rubber seal housing was removed patient status: no patient injury.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.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.

• 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: 6596113
• Report Number: 2027111-2017-01769
• Device Sequence Number: 16224277
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)200328(30)01(10)1293505
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: 5
• 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): 07/18/2017

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: 03/28/2020
• Device Model Number: 5
• Device Catalogue Number: 5
• Device Lot Number: 1293505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1