MAUDE Adverse Event Report: APPLIED MEDICAL CTB75, 12X100 KII SH BLD Z-THRD DP 10/BX; GCJ

Model Number	CTB75
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of 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
Urology - "during placement of the second trocar 5/12, the activated blade did not retract.Wound to the surgeon at one finger on the left hand.Cut with blood.Blade was soiled because it was used for the first trocar.Declaration to occupational medicine, sample patient serology." patient status - n/a.
Additional Manufacturer Narrative
Investigation summary: one (1) shielded bladed obturator and two (2) sleeves were returned for evaluation.Upon visual inspection, engineering confirmed there was no damage to any of the returned components.Initial testing revealed no issues with the mating interfaces, the actuation mechanism, or the locking mechanism.Engineering carried out an actuation test and verified that the kii shielded bladed obturator performed as intended and met all current specifications.During the manufacturing process, all trocars are thoroughly inspected and tested for functionality and performance prior to packaging.Additional information provided by the customer explained that the obturator "locking mechanism" was not activated before use in the second trocar when the injury to the operator occurred.The root cause of this event is likely due to the operator applying lateral force to the shield which exposed the side of the blade.

• Brand Name: CTB75, 12X100 KII SH BLD Z-THRD DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5645465
• Report Number: 2027111-2016-00359
• Device Sequence Number: 27571
• Product Code: GCJ
• UDI-Device Identifier: 00607915129910
• UDI-Public: (01)00607915129910(17)181215(30)01(10)1260970
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2016

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: CTB75
• Device Catalogue Number: 101351001
• Device Lot Number: 1260970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 08/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1