MAUDE Adverse Event Report: COOPERSURGICAL, INC. ENDOSEE HYSTEROSCOPE

Model Number ES8000

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Type  No Answer Provided  

Manufacturer Narrative

The device involved in the complaint will not be returned.Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed.(b)(4).Device not returned.

Event Description

"a patient stated that she obtained a bladder infection from the procedure.She went to her primary care after and medicine made the issue go away.The doctors office told me this as an fyi." (b)(4).

Manufacturer Narrative

(b)(4).Investigation: initiated manufacturer's investigation.X-no sample returned.Review dhr.Inspect returned samples.Inspect stock product.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.No unit was returned for evaluation.The endosee unit comprises of the tower and the cannula when in use.The tower section of the device does not enter the body as it is a display of what the camera captures when inserted into the area of interest.As the cannula is the section of the device that enters the body cavity there may be some involvement where the cannula may have been inadvertently contaminated by the end user.It is highly unlikely the cannula was the cause as all cannulas have been through a validated sterilization process prior to shipment.The root cause for this complaint condition is not available.Corrective actions: correction and/or corrective action: no unit sent in.No corrective actions are required at this time.A record of this complaint will be kept on file.Corrective action level 4 x-none.Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? no.Review and closure: capa required? recommended continuous improvement program (cip) complaint closure letter required? ncmr issued? other regulatory action needed: preventative action activity reviewed.Trend and monitor to cip.Device not returned.

Event Description

"a patient" "stated that she obtained a bladder infection from the procedure.She went to her primary care after and medicine made the issue go away.The doctors office told me this as an fyi." (b)(4).

• Brand Name: ENDOSEE HYSTEROSCOPE
• Type of Device: ENDOSEE HYSTEROSCOPE
• 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: 5614261
• MDR Text Key: 43846905
• Report Number: 1216677-2016-00029
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: ES8000
• Device Catalogue Number: ES8000
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other