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

Model Number F205

Device Problem Break (1069)

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

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently under investigation.(b)(4).

Event Description

Insulation chipped.(b)(4).

Event Description

Insulation chipped.Repair order log: 94281 reference e-complaint (b)(4).

Manufacturer Narrative

Investigation x-review dhr x-inspect returned samples *analysis and findings distribution history the complaint product was coated by a sub-supplier and packaged at coopersurgical.Manufacturing record review a review of recent dhr's (262115, 250905, 250903) did not find any non-conformities for this issue.Incoming inspection review a review of 2 year incoming inspection records for this product did not find any non-conformities for this issue.Service history record this product was returned on 5/15/20.Referencing repair order 94281, the instrument's coating was confirmed to be chipped.The instrument was scrapped and a replacement was sent to the customer.Historical complaint review a review of the 2-year complaint history showed a couple other complaints with a similar issue.Product receipt the returned speculum was sent back as a repair item on 5/15/20.Visual evaluation the returned speculum was visually inspected by the service and repair department (repair order 94281) and found to have a chip in the insulation coating.Functional evaluation the returned product was not functionally evaluated.Root cause a definitive root cause for this issue could 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 by the end user or due to normal wear.*correction and/or corrective action the complaint unit was scrapped and a replacement was sent to the customer.No training is required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• 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: 10140491
• MDR Text Key: 195233776
• Report Number: 1216677-2020-00130
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951898
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 11/18/2022
• 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