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

Model Number LP-50-101

Device Problems Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

2 hand controlled pencils failed during the same case.The button would not release thus energy continued to flow.They had to shut the power off to stop the energy.Ref e-complaint-2020-12-0000469 1216677-2020-00316 cautery pencil box of 10 lp-50-101 e-complaint-2020-12-0000469.

Event Description

2 hand controlled pencils failed during the same case.The button would not release thus energy continued to flow.They had to shut the power off to stop the energy.Ref (b)(4).1216677-2020-00316 cautery pencil box of 10 lp-50-101 (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr.Analysis and findings distribution history the complaint product was purchased from a supplier (symmetry surgical) and packaged by csi in april 2019 (lot 250651) and june 2019 (lots 256870, 256871).Manufacturing record review dhr19mpg004257 (250651), dhr19mpg002872 (256870) and dhr19mpg002445 (256871) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-19-02-27-008 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 attached 2-year complaint history showed no other similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: CAUTERY PENCIL BOX OF 10
• Type of Device: CAUTERY PENCIL BOX OF 10
• 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: 11150359
• MDR Text Key: 227746949
• Report Number: 1216677-2020-00316
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061651
• 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: 01/11/2021

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: LP-50-101
• Device Catalogue Number: LP-50-101
• Device Lot Number: 111229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other