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

Model Number LP-20-120

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Ref (b)(4).

Event Description

Over heating smells like something is burning.Order: (b)(4).Reference (b)(4).

Manufacturer Narrative

Ref: (b)(4).Investigation: x-inspect returned samples.Analysis and findings: distribution history: this complaint unit was manufactured at csi on 5/7/2015 under wo #: (b)(4) and shipped on 6/15/2015.Manufacturing record review: dhr's 177427 & 177435 were reviewed and non-conformities, unrelated 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) and received 1/24/2020.Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, the housing seam between the front plate and the chassis was noted to have a black char residue.Once opened, the source of the char was internal damage to the display board components, r9 & r14.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause : an initial investigation by technical operations (csi's engineering dept.) has indicated resistors r9 and r14 were burnt out due to being exposed to current outside their rating.The source of the power burning out the resistors has been determined to be t6, one of the transformers on the main board.The root cause of this issue has been attributed to under rated resistors and lack of specification on the t6 transformer.Correction and/or corrective action / preventative action activity: initial steps have screened incoming boards starting in october 2019 under non-routine inspections.The inspection was later formalized into procedure (b)(4) and included in the normal inspection criteria for the main board, p/n 300788-r.The inspection put in place calls for 100 % inspection on the t6 transformer.Once all corrections are executed on the ecn, this inspection can be removed.The resistors are to be reviewed for the potential for changing them to a higher rating and the transformer manufacture will be provided with specifications to check against.Additional steps to be worked out as the corrections move forward per capa 731.

Event Description

Over heating smells like something is burning.Order: (b)(4).Reference (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull, ct
• MDR Report Key: 9740136
• MDR Text Key: 191403503
• Report Number: 1216677-2020-00054
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K963348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other