MAUDE Adverse Event Report: COOPERSURGICAL, INC. KRONNER MANIPUJECTOR BOX; KRONNER MANIPUJECTOR BOX HUMI

Model Number 6003

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

"dr.(b)(6) from (b)(6) left me a voicemail (b)(6) 2015.He did an ultra sound on a pt and thinks he saw parts of the kronner in her from an operation 2 yrs ago.The pt has no symptoms and feels fine".(b)(4).

Manufacturer Narrative

Per dr.(b)(6): "the radiologist told him the plastic is 2-3cm in length and broken into 3 pieces.He honestly does not know how it could have been the kronner but he doesn't know what else it could be.Dr.(b)(6) also mentioned he would have been the one to remove the manipulator and did not notice anything wrong.I asked him if it could have been migration of a different product left in the abdomen.He said it the radiologist did not see anything indicating migration and that the plastic was located inside the cavity of the uterus.We basically came to the conclusion that it does not makes sense for it to be the kronner.Luckily the pt is a dentist and can understand how something like this can happen.She does not have any symptom and does not want to undergo surgery just to remove the pieces of plastic".Cooper surgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint will not be returned by the customer for eval.Once this investigation is completed, a f/u report will be filed.(b)(4).

Manufacturer Narrative

(b)(4).Investigation summary report : initiated manufacturer's investigation.No sample returned.The following is an acknowledgement of the reported event; "dr.(b)(6) from (b)(6) left me a voicemail (b)(6) 2015.He did an ultra sound on a patient and thinks he saw parts of the kronner in her from an operation 2yrs ago.The patient has no symptoms and feels fine." the remnants of a previous procedure were not definitively identified as stated in the complaint and therefore cannot be assumed that they are from a used csi product.Normal invasive medical procedure protocols calls for an inventory of materials and devices used in the procedure, and their physical state and completeness, it may be deduced from the complaint statement that this type of protocol was not practiced for the older two year old procedure.A review of the kroner inspection or lot dhr records could not be reviewed as the lot information was reported as unknown.Corrective action is not applicable as the affected sample is not being returned for investigative analysis, root cause is indeterminable.Per bsr-qar-026 this complaint will be monitored for trending in that no injury was reported to end user, or patient.

Event Description

"dr.(b)(6) did an ultrasound ona patient and thinks he saw parts of te kronner in her from an operation 2 years ago.The patients has no symptoms and feels fine." (b)(4).

• Brand Name: KRONNER MANIPUJECTOR BOX
• Type of Device: KRONNER MANIPUJECTOR BOX HUMI
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4739751
• MDR Text Key: 21056227
• Report Number: 1216677-2015-00011
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other