MAUDE Adverse Event Report: APPLIED MEDICAL C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX; GCJ

Model Number C0R47

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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.There is no report of serious injury or death associated with this event.

Event Description

Procedure performed unknown - "this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." complaint sheet - report from the sales rep: the seal dislodged from the cannula.Initial investigation report by (b)(4) olympus: the event unit was returned to olympus and visually inspected: the seal did not come off when pulled with the latch tabs not pressed; the latch tabs were not deformed.The unit will be returned to (b)(4) for further evaluation.Admin#(b)(4)." patient status - no patient injury.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Engineering was able to confirm the customer's experience of the seal being dislodged from the cannula; they noted that the seal could be dislodged from the cannula without pressing the latch tabs.The distance between the latch tabs was measured and was found to be out of specification.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to the distance between the two tabs not meeting specifications.Applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance with 21 cfr 803.56, if additional information is obtained 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: C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5677290
• MDR Text Key: 45856797
• Report Number: 2027111-2016-00395
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453(17)181210(30)01(10)1260197
• Combination Product (y/n): N
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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
• Device Operator: Other
• Device Expiration Date: 12/10/2018
• Device Model Number: C0R47
• Device Catalogue Number: 101246101
• Device Lot Number: 1260197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1