MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

Model Number LP-10-120

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.

Event Description

Report submitted by csi service and repairs -"a sales rep noted on this first use today of leep precision # (b)(4) that the fuses on the leep and cart blew out.The leep housing became very hot.No patient involvement." (b)(4).

Event Description

Report submitted by csi service and repairs -"a sales rep noted on this first use today of leep precision # (b)(6) that the fuses on the leep and cart blew out.The leep housing became very hot.No patient involvement." reference 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 2/25/2020 under wo #(b)(4) and shipped on 3/18/2020.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 a couple similar reported complaint conditions.No additional detail on what the issue could be was available on the complaints.New boards were put in the units and the old ones were discarded.Product receipt: the complaint unit was returned on rma (b)(4).Visual evaluation: visual examination of the complaint unit revealed no outer physical damage.However, internally, the main transformer attached to the top housing clearly showed signs of heat damage to the clear covering exposing the copper wire windings.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Several set of fuses were re-installed confirming the unit burns out fuses on the generator only.The fuses on the smoke evacuator were not affected by this failure.Root cause : an evaluation of the unit by the vs engineer pinpointed the source of the failure to the large transformer.Failure is being attributed to loss of isolation between the windings above allowable tolerances.The thin covering on the copper wire became insufficiently insulated from each other creating the failure condition.Isolated incident.*correction and/or corrective action the customer received a new generator.The complaint unit was converted to a demo unit under wo #(b)(4).The defective transformer (fully dressed p/n 300791-raw p/n 109707) was removed and sent to the transformer vendor for additional evaluation under ncmr (b)(4).No further training required at this time.*preventative action activity reference ncmr (b)(4).

• Brand Name: LEEP PRECISION INTG. SYS.
• Type of Device: LEEP PRECISION INTG. SYS.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 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: 10091786
• MDR Text Key: 194944495
• Report Number: 1216677-2020-00125
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other