MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR74, KII 12X100 Z-THR OSEP SYS HN 6/BX; GCJ

Model Number	CTR74
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown event description: "near the end of the procedure, the surgical team noticed a black item inside the patient's abdomen.It was retrieved from inside the patient with no patient harm reported.Through investigation by the hospital, it was observed that a piece of the inside of the trocar (black rubber) had broken off.Pictures attached to associated email." type of intervention: unknown.Patient status: "no adverse patient outcome.".
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation with a rubber fragment.Visual inspection confirmed the complainant's experience of fragmentation of an internal rubber component of the seal.The rubber fragment returned matched the missing portion on the seal.Based on the condition of the returned unit and description of the event, it is likely that the reported event was caused by 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 continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CTR74, KII 12X100 Z-THR OSEP SYS HN 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6941047
• Report Number: 2027111-2017-02040
• Device Sequence Number: 19005815
• Product Code: GCJ
• UDI-Device Identifier: 00607915123697
• UDI-Public: (01)00607915123697(17)200203(30)01(10)1288814
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 02/03/2020
• Device Model Number: CTR74
• Device Catalogue Number: 101470926
• Device Lot Number: 1288814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1