MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.0 ULTEM KOH-EFF

Model Number AD750-KE30

Device Problems Break (1069); Inflation Problem (1310); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

Once uterine manipulator was placed, the tip balloon popped.Multiple were used and balloons popped.Two popped while inside uterus one did not inflate.Additional information- customer called me and the physician on this case went through multiple delineators with issues with the tip balloon popping.Patient was ridden with fibroids and after speaking with the physician, it could have been patient anatomy.Just want to make sure the integrity of our tip balloons are not the problem.No adverse event reported / no medical attention.1216677-2022-00089 sterile 3-0 ultem koh-eff ad750-ke30 e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported conditon.

Event Description

Once uterine manipulator was placed, the tip balloon popped.Multiple were used and balloons popped.Two popped while inside uterus one did not inflate.Additional information- customer called me and the physician on this case went through multiple delineators with issues with the tip balloon popping.Patient was ridden with fibroids and after speaking with the physician, it could have been patient anatomy.Just want to make sure the integrity of our tip balloons are not the problem.No adverse event reported / no medical attention.Follow-up response- procedure being performed? robotic total laparoscopic hysterectomy.Placed multiple manipulators until a tip balloon was functioning properly.No fragments left in the patient.No significant time delay, just the time delay in getting a manipulator that the tip.Balloon worked properly and the physician felt comfortable to proceed with the case.Sterile 3-0 ultem koh-eff ad750-ke30.E-complaint: (b)(4).

Manufacturer Narrative

Investigation : initiated manufacturer's investigation.Review dhr.Inspect returned samples.Analysis and findings : distribution history: the complaint product was manufactured at csi on 10/26/2021 under work order (b)(4).Manuf.Record review: dhr - 310974 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service hist.Record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history showed similar reported complaint conditions, where the distal balloon leaked during use.Product receipt the complaint unit was returned on 06/16/22.Visual eval: visual examination of the complaint unit revealed a large cut on the distal balloon.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.When the distal balloon was inflated, the distal balloon did not inflate due to leak caused by a cut on the distal balloon, and one where it appears the balloon had burst.Additionally another sample would not inflate.When unit was investigated, the tail indicator portion was very loose, indicating that the tail portion may have been pulled out with force.The loose tail indicator end can be pulled out about.5 inch.Root cause: the root cause of this issue has been attributed to the distal balloon of the device coming into contact with a sharp object during use, and as well as overinflation, beyond the 10cc specified under 38501-ifu.For the unit where the distal balloon was not inflated, the indicator tail tube underwent a large enough force to dislodge the tube from the internal metal tube, causing a gross leak.During manufacture of the device, the distal balloon is checked for gross leak, and a cut and dislodged tube such as that found on the returned devices would have been rejected.Therefore, the root cause of the leak on the distal balloon is not considered to be a manufacturing issue.The ifu (38501-ifu-b) that accompanies the product mentions that prior to use, both balloons need to be test inflated and deflated to verify that the balloon is in working condition.The complaint unit was soiled with blood indicating that the product started leaking during use, and not prior, during the inflation test as noted in the ifu.Corrective actions: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not attributed to be a manufacturing issue.The product met the required release specifications per dhr review.No re-training required.Was the complaint confirmed? yes.

• Brand Name: STERILE 3.0 ULTEM KOH-EFF
• Type of Device: STERILE 3.0 ULTEM KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 13826591
• MDR Text Key: 294507092
• Report Number: 1216677-2022-00089
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AD750-KE30
• Device Catalogue Number: AD750-KE30
• Device Lot Number: 310974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other