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

Model Number LP-20-120

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Customer stated-blowing fuses.Complaint verified-transformer no good, blows fuses ro 96984.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 11/12/2020 under wo#'s: (b)(4) and shipped on 12/21/2020.Manufacturing record review: dhrs: (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 similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.However, based on log: (b)(4), this unit was at csi on 9/10/2021.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to not function properly.Root cause: the root cause for this complaint condition is due to a short between windings on the main transformer, p/n: 300791, (p/n: 109707).Was the complaint confirmed? yes.Correction and/or corrective action: the unit was fitted with a new transformer, the board was updated to latest revision, tested to specifications and returned to the customer.The shorts on the main transformer was confirmed to have been due to the vendor's process.No specific detail on the process was made available other than a description of the process with the vendor.Also, the testing by the vendor was confirmed to be inadequate to find shorts between windings, hence the vendor's hi-pot testing scheme for the transformers was updated with csi input.Units in wip were checked under eng-btest-00236 with one dressed and one undressed transformer were rejected.The change in the testing by the vendor was made at the end of october 2020 and incorporates additional steps to check for potential shorts between windings.The issue was determined to be a recent occurrence with the latest shipments and not found to affect every unit.Addressing units in wip by stressing the transformers was determined to be sufficient containment.

Event Description

Customer stated-blowing fuses.Complaint verified-transformer no good, blows fuses ro 96984.1216677-2021-00229 leep precision generator lp-20-120 e-complaint: (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• 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: 12624547
• MDR Text Key: 278590484
• Report Number: 1216677-2021-00229
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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: Health Professional
• 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
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 03/11/2022
• 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