MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP VU-MAX GRAVES LARGE

Model Number F219

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently under investigation.A follow - up report will be filed once the investigation has been completed and the findings are available.Ref e-complaint (b)(4).

Event Description

Per e-mail report - failed insulation testing.Reference e-complaint (b)(4).

Manufacturer Narrative

Ref (b)(4).*investigation x-inspect returned samples.*analysis and findings distribution history the complaint product was purchased from a supplier who coated the instrument in september 2018.The product was packaged under work order (b)(4) and sold to this customer on (b)(6) 2019.Manufacturing record review a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed and this complaint amended accordingly.Incoming inspection review iqc record-18-09-25-010 was reviewed for supplier lot number 1807232 and no non-conformities were noted.Service history record service history not applicable for this product.Historical complaint review a review of the attached 2-year complaint history showed one other similar reported complaint condition from the same customer.Product receipt the complaint product was returned on 9/21/19.The lot number of the returned product did not match the lot number reported.The actual lot number on the product is 1807232 not 395841 as reported.Visual evaluation visual examination of the complaint unit revealed no physical damage.Functional evaluation a hi-pot electrical test was performed per sop-gynce-002 and the returned product was found to be acceptable.Root cause the returned product tested to specification and was found to meet all visual and functional test specifications.The complaint condition could not be confirmed.*correction and/or corrective action corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.*was the complaint confirmed? no.*preventative action activity coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Per e-mail report - failed insulation testing.Reference (b)(4).

• Brand Name: LEEP VU-MAX GRAVES LARGE
• Type of Device: LEEP VU-MAX GRAVES LARGE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9111224
• MDR Text Key: 190543010
• Report Number: 1216677-2019-00262
• Device Sequence Number: 1
• Product Code: HDF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: F219
• Device Catalogue Number: F2219
• Device Lot Number: 395841
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other