MAUDE Adverse Event Report: COOPERSURGICAL, INC. HANDPIECE BOX OF 10

Model Number 6040

Device Problem Defective Component (2292)

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

Event Date 01/27/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.Ref e-complaint-(b)(4).

Event Description

"the cautery failed during leep procedure." ref e-complaint-(b)(4).

Manufacturer Narrative

Ref (b)(4).Investigation: no sample returned, review dhr.Analysis and findings: it has been approximately 65 days and the reported sample has not been returned for investigative analysis.The handpiece is purchased from and pouched by a supplier.The individual pouches are placed into packaging at coopersurgical.A review of two year complaint history shows no complaints for this issue.A review of the dhr (171329) did not show any abnormalities.The product was packaged at coopersurgical in february 2016.Lot 037886 has been depleted from finished goods inventory.The reported complaint could not be verified or confirmed due to the affected sample not being returned for investigative analysis.Based on the information from above, the reported complaint is considered an isolated incident.Correction and/or corrective action: none.Reason: no further action is needed at this time.However, this complaint will be reopened and re-evaluated should the samples be returned.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"the cautery failed during leep procedure." ref (b)(4).

• Brand Name: HANDPIECE BOX OF 10
• Type of Device: HANDPIECE BOX OF 10
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8336650
• MDR Text Key: 136787606
• Report Number: 1216677-2019-00031
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• PMA/PMN Number: K884174
• 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: 12/08/2019

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 Expiration Date: 05/28/2020
• Device Model Number: 6040
• Device Catalogue Number: 6040
• Device Lot Number: 037886
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other