MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along 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 did not complete the seal when reassembled.Based on the condition of the returned unit, 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.This report represents the initial and final report.
Event or Problem Description
Procedure performed: ni.Event description: during laparoscopy, it was found a black piece of plastic.This piece of plastic could correspond to a part of the anti-return valve of the trocar.The piece was removed and the trocar changed.Type of intervention: a second device was used.Patient status: unknown.

• Brand Name: CTB73, 12X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6919322
• Report Number: 2027111-2017-02029
• Device Sequence Number: 19045414
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)200228(30)01(10)1290306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2017

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: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1290306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1