MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 4.0 SOFT KOH-EFF; UTERINE MANIPULATOR, SINGLE-USE

Model Number AD750SC-KE40

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

It was reported that during a lap hysterectomy the balloon from advincula delineator was removed from the manipulator and left in the patient.Complainant recommend that the balloon (pneumo occluder) not be a detachable item.No adverse event reported.No additional information.Ad750sc-ke40 sterile soft koh 2023-07-0000297.

Manufacturer Narrative

Customer has indicated that the product will not be returned to cooper surgical for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Distribution history: the complaint product was manufactured at csi stafford on 05/10/21 under work order (b)(4).Manuf.Record review: dhr - 239059 and sub-assembly used dhr-300638 for pn:23667-1 occluder balloon were 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 did not show similar reported complaint conditions, where slips.Product receipt the complaint product has not been returned to coopersurgical.Visual eval.Evaluation of the complaint unit could not be completed as the complaint unit has not been returned.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation of the complaint unit could not be completed as the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause during investigation it was found that dhr-300638 was used to assemble the complaint product, no non-conformities, related to the complaint condition, were noted.It is possible that during usage the device was removed from the patient without deflation of the occluder balloon, causing the balloon to slip off, the product ifu mentions prior to removing the advincula delineator from the uterus, remove air from both the uterine tip balloon and the pneumo occlusion balloon.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

Event Description

No additional information is available.

• Brand Name: STERILE 4.0 SOFT KOH-EFF
• Type of Device: UTERINE MANIPULATOR, SINGLE-USE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17396695
• MDR Text Key: 320041079
• Report Number: 1216677-2023-00108
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937021370
• UDI-Public: (01)00888937021370(10)305275(17)240510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AD750SC-KE40
• Device Catalogue Number: AD750SC-KE40
• Device Lot Number: 305275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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 Age: 21 YR
• Patient Sex: Female