MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP VUMAX PEDERSON MED.

Model Number F222

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

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

Event Date 08/22/2019

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.(b)(4).

Event Description

Per telephone report- device failed coded insulated instrument testing.(b)(4).

Manufacturer Narrative

Ref e-complaint:(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 (b)(6) 2015.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 (see attachment) was reviewed for supplier lot number 1412092 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 attached 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product was returned on 9/25/19.The lot number of the returned product matched the lot number reported.Visual evaluation visual examination of the complaint unit revealed no physical damage.Functional evaluation a hi-pot electrical test was performed per (b)(4) 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 reported 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 telephone report- device failed coded insulated instrument testing.Reference e-complaint-(b)(4).

• Brand Name: LEEP VUMAX PEDERSON MED.
• Type of Device: LEEP VUMAX PEDERSON MED.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8949200
• MDR Text Key: 156404763
• Report Number: 1216677-2019-00240
• 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: 12/18/2019

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 Operator: No Information
• Device Model Number: F222
• Device Catalogue Number: F222
• Device Lot Number: 1412092
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other