MAUDE Adverse Event Report: COOPERSURGICAL, INC. GRAVES SPECULUM MEDIUM

Model Number F205

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

There is a nick in it where there is no coating.Graves speculum medium f205 (b)(4).

Manufacturer Narrative

Investigation : x-review dhr: x-inspect returned samples: *analysis and findings.Distribution history: the complaint product was purchased from and coated by a sub-supplier (vitek), lot 2002101 in april 2020 and packaged by csi in may 2020 under work order 267363.Manufacturing record review: dhr 267363 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-20-04-24-002 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: no service history record found for this product.Historical complaint review: a review of the 2-year complaint history showed some similar reported complaint conditions.Product receipt: the complaint product was returned.The lot number of the returned product matched the lot number reported.Visual evaluation visual examination of the complaint product found a nick in the insulation coating on the top blade of the speculum.There was slight damage in the same area of the bottom blade that did not penetrate the coating.Functional evaluation: the returned product was not functionally evaluated.Root cause a definitive root cause for this issue could not be reliably determined at this time.Since the instrument is 100% hi-pot tested at the coating supplier and sampled at coopersurgical incoming inspection, it is suspected the chipped coating may have occurred due either to improper handling and/or damaging impact after leaving the facility.*correction and/or corrective action: no corrective action is required at this time.No training required at this time.*preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

There is a nick in it where there is no coating.1216677-2021-00096 graves speculum medium f205 (b)(4).

• Brand Name: GRAVES SPECULUM MEDIUM
• Type of Device: GRAVES SPECULUM MEDIUM
• 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: 11797134
• MDR Text Key: 252343881
• Report Number: 1216677-2021-00096
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 2002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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