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

Model Number LP-20-120

Device Problems Break (1069); Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported.

Event Description

Burnt fuses, unit hot.Order: 94944.Complaint verified.Replaced transformer and fuse.Follow up comments from s&r: the transformer insulation was breaking down causing the transformer to heat up.The fuse blew stopping the power from reaching the transformer.So the fuse, which acts as a safety device, blew before the transformer could damage the unit.Ref : e-complaint-(b)(4).Leep precision generator lp-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 4/16/2020 under wo #'s (b)(4) and shipped on 6/9/2020.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 one similar reported complaint condition.Product receipt: the complaint unit was returned on repair log (b)(4).Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, once the unit was opened burn damage was evident the transformer p/n 300791.Functional evaluation: complaint unit was functionally evaluated and found to not function properly.Root cause : a short was detected on the secondary winding of the transformer.A failure like this will prevent the unit from being powered up due to the increase in amperage, the short reduces the resistance, which in turn burns out the fuses on the power inlet.The fuses are rated for 3.15 amps.*correction and/or corrective action the unit was repaired and returned to the customer under warranty.The transformer was torn down by the vendor and confirmed the failure was due to a short.Initially, the vendor indicated impact may have played a roll but csi is investigating further and has noted one other transformer had a gap in the wrapping between the high and low voltage wrappings.A definitive root cause is not readily available at this time.All findings to date suggest a process issue at the vendor coupled with a lack of sufficient checks.Corrective actions to be noted on ncmr 13378.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Burnt fuses, unit hot.Order: (b)(4).Complaint verified.Replaced transformer and fuse.Follow up comments from s&r: the transformer insulation was breaking down causing the transformer to heat up.The fuse blew stopping the power from reaching the transformer.So the fuse, which acts as a safety device, blew before the transformer could damage the unit.Ref : (b)(4).1216677-2020-00234 leep precision generator lp-20-120 (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• 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: 10694609
• MDR Text Key: 213503929
• Report Number: 1216677-2020-00234
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• 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