MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR REFURB

Model Number DMLP-20-120

Device Problem Insufficient Information (3190)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.

Event Description

Unit in for evaluation.Pcb was replaced.Order: 94637.Ref: e-complaint-(b)(4).Refurb leep precision gen dmlp-20-120 e-complaint-(b)(4).

Manufacturer Narrative

Investigation.X-review dhr x-inspect returned samples.Analysis and findings complaint #(b)(4).Distribution history: this complaint unit was manufactured at csi on 8/20/2015 under wo #'s (b)(4) and shipped on 10/2/2015.It was later converted to a demo unit under wo #(b)(4) on 7/18/2016 and shipped on 12/24/2018.Manufacturing record review: dhr's (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 94637.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause : the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as there is no specific failure provided to confirm to.Correction and/or corrective action: although the unit passed all testing specifications the board was suspect and the unit was fitted with a new board as a precaution.The board (pg16050069) was set aside for additional review by engineering at a later time.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required at this time.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Unit in for evaluation.Pcb was replaced.Order: (b)(4).Ref: (b)(4).1216677-2020-00181 refurb leep precision gen dmlp-20-120 (b)(4).

• Brand Name: LEEP PRECISION GENERATOR REFURB
• Type of Device: LEEP PRECISION
• 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: 10432073
• MDR Text Key: 209029908
• Report Number: 1216677-2020-00181
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DMLP-20-120
• Device Catalogue Number: DMLP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other