MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 SOFT KOH-EFF; STERILE 3.5 SODT KOH-EFF

Model Number AD750SC-KE35

Device Problem Melted (1385)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

Per medwatch-uf_importer# (b)(4).The uterine manipulator device appeared to be melting during the colpotomy portion of a procedure as robotic arm was cutting/coagulating the tissue from the device.No harm came to the patient or healthcare provider and the procedure was finished as planned other contact- (b)(6).Follow-up initiated for product return.Sterile 3-5 soft koh-eff ad750sc-ke35 e-complaint- (b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Per medwatch-uf_importer# (b)(4) - the uterine manipulator device appeared to be melting during the colpotomy portion of a procedure as robotic arm was cutting/coagulating the tissue from the device.No harm came to the patient or healthcare provider and the procedure was finished as planned other contact- (b)(4).Follow-up initiated for product return.1216677-2021-00263 sterile 3-5 soft koh-eff (b)(4) e-complaint(b)(4).

Manufacturer Narrative

Investigation.X-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings: distribution history.The complaint product was manufactured at csi on 03/26/21 under work order 300564.Manuf.Record review.Dhr - 300564 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 attached 2-year complaint history showed similar reported complaint conditions, where the cup were showing signs of melting.Product receipt.The complaint product has not been returned to coopersurgical.There is currently no rma for the product.Visual eval.Evaluation of the complaint product could not be completed as the complaint product has not been returned.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, the complaint similar to other complaints as mentioned earlier.Quality engineering, research and development, marketing, and product surveillance conducted an investigation into 4 advincula soft koh-efficient product complaints from kaiser, where small fragments (~1mm) of the soft cup either became damaged or melted, disengaging from the cup.*was the complaint confirmed? no.Root cause.The root cause of this issue has been previously attributed to a technique during a colpotomy, in which constant movement of the electrosurgical unit (esu) cutting tip is necessary.For example, if the end user does not keep the esu tip moving and remains in one place on tissue for an extended period of time, the advincula soft cup material may begin to melt.As a result from previous complaints, capa 722 was initiated to determine a different type of material - resulting in changing the material from isothane 5095a to hytrel sc976.As the complaint condition was not confirmed, nor are there any information as to how the product was used, the root cause for this complaint cannot be readily determined at this time.Correction and/or corrective action.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: STERILE 3.5 SOFT KOH-EFF
• Type of Device: STERILE 3.5 SODT KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 13074972
• MDR Text Key: 284806991
• Report Number: 1216677-2021-00263
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750SC-KE35
• Device Catalogue Number: AD750SC-KE35
• Device Lot Number: 300564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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