MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP GRAVES SPEC LARGE

Model Number 61515

Device Problem Material Integrity Problem (2978)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Related complaint e-complaint(b)(4).Ongoing concerns with speculum coating bubbling that started with a few graves speculums # 61515 and #61514 before reprocessing and now has begun happening to more speculums with reprocessing.The insulation appears to be cracked which causes bulging in insulation weak spots.Concern was brought forward to vendor in may and continues to be a concern.Mdrd has verified with mifu and can confirm that sterilization on the insulated speculum are at the validated parameters.Did the incident occur before, during, or after a procedure? before.Patient, gamete, embryo, or end user involvement? yes.Any patient injury or impact to the gamete or embryo? no.Medical or procedural intervention? no.Patient/gamete/embryo status: n/a.Follow-up response: lot numbers cannot be found on these items.Additional follow-up response: mostly cracked and yes some metal exposed.Leep graves spec large 61515 e-complaint(b)(4).Feedback from csi service and repair : if cracked or chipped, there is a chance the patient could be shocked by the leep electrode touching bare metal on the speculum.Bubbling and cracking are both caused by excessive heat or using a caustic chemical to clean the units.

Manufacturer Narrative

Investigation: no sample returned analysis and findings: distribution history: the complaint product was purchased from murph industries llc.Manufacturing record review: manufacturing record review is not applicable for this product.Incoming inspection review: a review of the incoming inspection record could not be performed because the complaint product lot/serial number was not provided.Should the complaint product lot/serial number be provided going forward, the incoming inspection report will be reviewed, and this complaint amended accordingly.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.A concern of bubbling in the speculum coating.Also, no crack on the product has been reported in the past.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.However, based on the pictures that have been provided by the customer, they revealed a crack on the product, see below picture.There were no bubbles identified on the provided pictures.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: while no definitive root cause could be reliably determined, the potential cause of bubbling and cracking are both may be caused by excessive heat or using a caustic chemical to clean the units (based on the customer's provided pictures and the coopersurgical service department comment).Corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.Was the complaint confirmed? yes.

Event Description

Speculum coating bubbling.The insulation appears to be cracked.Leep graves spec large 61515 (b)(4).

• Brand Name: LEEP GRAVES SPEC LARGE
• Type of Device: LEEP GRAVES SPEC LARGE
• 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: 15778851
• MDR Text Key: 307600258
• Report Number: 1216677-2022-00296
• Device Sequence Number: 1
• Product Code: HDF
• UDI-Device Identifier: 00888937026818
• UDI-Public: 888937026818
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61515
• Device Catalogue Number: 61515
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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