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

Model Number F232

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

Report stated coating is coming off.Leep auvard speculum lg f232 e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation.X-no sample returned.X-review dhr.*analysis and findings : distribution history: the complaint product (lot 1911141) was purchased from reda then sent for coating by vitek, packaged by csi on (b)(6) 2020 under work order (b)(4) , and sold on (b)(6) 2022.Manufacturing record review: (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc record- f232-01 (coated part received from vitek) was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed one additional similar reported complaint conditions.There is one additional complaint from a different lot regarding chips in the coating.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.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.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: 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.No further training required at this time.*preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.**please note the following corrections to previous report - file name: (b)(4).Status: delivered.**manufacturer report number 1216677-2022-00199.Previously incorrectly submitted as 1216677-2021-00199.**b5 referenced submission name 1216677-2021-00199 leep auvard speculum lg f232 (b)(4).Previously incorrectly referrenced as 1216677-2021-00199 leep auvard speculum lg f232 (b)(4).Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report stated coating is coming off.1216677-2022-00199 leep auvard speculum lg f232 (b)(4).

• Brand Name: LEEP AUVARD SPECULUM LG
• Type of Device: LEEP AUVARD SPECULUM LG
• 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: 14887686
• MDR Text Key: 303349305
• Report Number: 1216677-2021-00199
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: F232
• Device Catalogue Number: F232
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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