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

Model Number 61514

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.

Event Description

Report stated "the rose coloured insulation on the speculum is chipping after autoclaving." (b)(4).Leep graves spec med 61514.

Event Description

Report stated "the rose coloured insulation on the speculum is chipping after autoclaving.".Ref e-complaint- (b)(4).1216677-2020-00102 leep graves spec med 61514 e-complaint- (b)(4).

Manufacturer Narrative

Investigation.X-inspect returned samples.*analysis and findings.Distribution history.The complaint unit was purchased from murph industries.It was sold to customer on \(b)(6) 2019.Manufacturing record review.Manufacturing record review not applicable to this complaint.Incoming inspection review a review of the incoming inspection record could not be performed because the complaint product lot number was not provided.Should the complaint product lot number be provided going forward, the incoming inspection report will be reviewed, and this complaint amended accordingly.Service history record.No previous service history record found for the products.Historical complaint review a review of the 2-year complaint history did not show similar complaint condition of bubbles.Product receipt.The complaint product was returned to coopersurgical on(b)(6) 2020.Visual evaluation.Visual examination of the complaint product confirmed chipped coating.Functional evaluation functional examination of the complaint product confirmed chipped coating.Root cause while no definitive root cause could be reliably determined, the potential cause may be improper user handling.Chipped coating is an indication of improper sterilization.Refer to the attached sterilization instruction.*correction and/or corrective action no further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP GRAVES SPEC MED
• Type of Device: LEEP GRAVES SPEC MED
• 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: 10012979
• MDR Text Key: 194944243
• Report Number: 1216677-2020-00102
• Device Sequence Number: 1
• Product Code: HDF
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 61514
• Device Catalogue Number: 61514
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other