MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP AUVARD SPECULUM MED

Model Number F205

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

There is a spot that is missing coating.Leep auvard speculum med f230 (b)(4).

Event Description

There is a spot that is missing coating.1216677-2021-00094.Leep auvard speculum med f230 (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr *analysis and findings distribution history the complaint product was coated by a sub-supplier (vitek) in (b)(6) 2019 and packaged by csi in december 2019 under work order (b)(4).Manufacturing record review dhr-267345 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.It should be noted that a hi-pot test is conducted on a sampling of instruments after being coated.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product is not available at this time.If the product should be available at a later date, it will be evaluated, and any findings will be appended to this investigation visual evaluation the complaint product is not available at this time.If the product should be available at a later date, it will be evaluated, and any findings will be appended to this investigation functional evaluation the complaint product is not available at this time.If the product should be available at a later date, it will be evaluated, and any findings will be appended to this investigation root cause root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP AUVARD SPECULUM MED
• Type of Device: LEEP AUVARD SPECULUM 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: 11797322
• MDR Text Key: 252342199
• Report Number: 1216677-2021-00094
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/01/2022

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 Model Number: F205
• Device Catalogue Number: F205
• Device Lot Number: 1909163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other