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

Model Number 6003

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.

Event Description

Received under medwatch mw5086410.Customer stated "the kronner uterine manipulator would not deflate.Md cut the inflation tip off to see if it would deflate, but it did not.Successfully removed and no pieces left behind, no injury to patient." (b)(4).

Event Description

Received under medwatch mw5086410.Customer stated "the kronner uterine manipulator would not deflate.Md cut the inflation tip off to see if it would deflate, but it did not.Sucessfully removed and no pieces left behind, no injury to patient." reference (b)(4).

Manufacturer Narrative

Ref.(b)(4).*investigation: x-initiated manufacturer's investigation.X-review dhr.X-inspect returned samples.Analysis and findings: distribution history.The complaint product was purchased from geo tech, packaged by csi on 03/22/2019 thru 3/27/2019 under work order 258155.Manufacturing record review: dhr-6003-258155 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: a review of the incoming inspection record could not be performed as the record could not be located at the time of this investigation.If the incoming inspection record should be located going forward, it will be reviewed, and this complaint amended accordingly.Service history record.Service history not applicable for this product.Historical complaint review.A review of the attached 2-year complaint history did show similar reported complaint conditions.Product receipt: the complaint product was received with rma 295568, 5/31/2019.Visual evaluation.Visual examination of the complaint product was performed and reported complaint event was confirmed.Functional evaluation.Functional evaluation is not applicable to this complaint.Root cause: review of past similar complaints for this product family determined that the most likely cause was attributed to improper use or mishandling of the device contrary to the dfu instructions for use.Correction and/or corrective action: coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time.

• Brand Name: KRONNER MANIPUJECTOR BOX
• Type of Device: KRONNER MANIPUJECTOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct CT 06611
• MDR Report Key: 8633435
• MDR Text Key: 146048652
• Report Number: 1216677-2019-00085
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K904473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/21/2022
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Device Lot Number: 258155
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other