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

Model Number AD750-KE30

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Nurse called and said the item ad750-ke30 was defective.During a procedure the blue cuff ring chipped while in the patient upon examination, multiple damage areas were noted, procedure was completed but patient was injured.Sterile 3-0 ultem koh-eff ad750-ke30 e-complaint- (b)(4).

Event Description

Nurse called and said the item ad750-ke30 was defective.During a procedure the blue cuff ring chipped while in the patient upon examination, multiple damage areas were noted, procedure was completed but patient was injured.1216677-2022-00317 sterile 3-0 ultem koh-eff ad750-ke30 e-complaint-(b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation.X-review dhr.X-inspect returned samples.*analysis and findings distribution history the complaint product was manufactured at csi on 01/11/21 under work order 299070.Manuf.Record review dhr - 299070 was reviewed and was found to have non-conformity unrelated to the complaint condition.The work order was reworked and subsequently resubmitted for qc inspection and passed.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 the cup was chipped on this product.Product receipt the complaint product was returned.Visual eval.Visual examination of the complaint unit revealed the cup showing signs of melting from encountering an energized source.Functional evaluation the returned sample shows a cup with a melted edges, indicating that the plastic was exposed to an energized source.The cup was still in tact, however, it had melted gashes as seen in the picture.Root cause the root cause of this issue has been 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 cup material may begin to melt.A metal ringed variety can be used in conjunction with an energized cutting tool.The melted cup due to exposure to an energized cutting source is not a manufacturing defect.*correction and/or corrective action coopersurgical will continue track and trending of the complaint condition.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: STERILE 3.0 ULTEM KOH-EFF
• Type of Device: STERILE 3.0 ULTEM 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: 13210707
• MDR Text Key: 285736251
• Report Number: 1216677-2021-00317
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750-KE30
• Device Catalogue Number: AD750-KE30
• Device Lot Number: 299070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other