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

Model Number	CTS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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.
Event or Problem Description
Laparoscopically assisted vaginal hysterectomy (lavh) - "a piece of the rubber seal became loose and dropped into the abdominal cavity.When using the laparoscopic knot tying device and while lowering/tightening the knot, a piece of rubber dropped into the abdominal cavity." patient status: unknown.
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Correction: trocar model updated to cts12, 11x100 kii sleeve zthr 12/bx.(suspect medical device, brand name and model number; all manufacturers, 5.Pma/510(k)) investigation summary: the event unit was returned for evaluation.It is important to note that the original customer experience report had the incident device recorded as a ctf33, 11 x 100 kii fios z-thread trocar model, however, the actual product that was returned by the customer was a cts12, 11x100 kii sleeve zthr 12/bx trocar.Upon inspection, engineering noted no visible damage to the exterior of the device.Engineering noted the duckbill and septum were torn and the septum was found to be missing a portion.The missing portion of the rubber was returned and matches the hole in the septum.All seals are thoroughly inspected and tested for leakage during the manufacturing process.The damage to the septum appears to have been caused by an instrument.There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices.The instructions for use (ifu) warns that extra care should be used when inserting angular and asymmetrical instruments.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 and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: CTS12, 11X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5749046
• Report Number: 2027111-2016-00465
• Device Sequence Number: 10763270
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)181215(30)01(10)1260683
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 05/25/2016

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: 12/15/2018
• Device Model Number: CTS12
• Device Catalogue Number: 101244901
• Device Lot Number: 1260683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2016
• Supplement Report FDA Received Date: 08/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1