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

Model Number F232

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Multiple chip on speculum after use.Leep auvard speculum lg f232 (b)(4).

Manufacturer Narrative

Investigation: x-review dhr: x-inspect returned samples.Analysis and findings: distribution history: the complaint product was coated at a supplier in november 2017 under work order (b)(4), was packaged at csi in may 2018 under (b)(4) and sold on 9/1/20.Manufacturing record review (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc record- (b)(4) 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 did not show similar reported complaint conditions.Product receipt: the complaint product (1 piece of leep auvard speculum) was returned without the box on 10/5/20.The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed a nick mark on the coating of the instrument.Functional evaluation: complaint product was functionally evaluated per a dielectric test (hi-pot) and found not to function properly at the nick mark.Root cause: while no definitive root cause could be reliably determined, the potential cause may be due to mishandling of instrument after leaving the csi facility which led to the damage of the protective coating.It should be noted that the coating supplier 100% functionally test each instrument using a hi-pot tester.Also, csi performs an aql sampling functional hi-pot test on each shipment for this part.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Multiple chip on speculum after use.1216677-2020-00219 leep auvard speculum lg f232 e-complaint (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: 10630778
• MDR Text Key: 233170008
• Report Number: 1216677-2020-00219
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: 1708151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• 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