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

Model Number LP-20-120

Device Problems Thermal Decomposition of Device (1071); Nonstandard Device (1420)

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

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

R9 and r14 burnt component recall (b)(4).

Event Description

R9 and r14 burnt component recall - sn (b)(4) unit.Ref (b)(4).

Manufacturer Narrative

(b)(4).Investigation: x-review dhr, x-inspect returned samples.Analysis and findings.Distribution history: this complaint unit was manufactured at csi on 10/13/16 under wo #'s (b)(4) & (b)(4) and shipped on 11/22/16.Manufacturing record review: dhr's (b)(4) & (b)(4) were reviewed and non-conformities, unrelated to the complaint condition, were noted.None of the observed notes indicate a similar issue.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the attached 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 297150 under recall and received on 10/24/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, once the unit was opened burn damage was evident on r9 and r14 on the display board.Functional evaluation: complaint unit was functionally evaluated and found 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 device.The root cause of this issue has been attributed to under rated resistors and lack of specification on the t6 transformer.Note: this unit is on recall 1216677-05-24-2019-002r for an unrelated correction by the addition of a zener diode.Correction and/or corrective action: the recall correlates with the findings and corrections in capa (b)(4).This unit was processed per the corrective actions established pertaining to the potential for foot pedal failures.The recall units are fitted with a zener diode, but due to the additional defect finding, this unit was fitted with an entire new board under wo #(b)(4).The finding on this unit pertaining to the burnt resistors are to be addressed on capa (b)(4).No further training required at this time.Was the complaint confirmed? yes.

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9341426
• MDR Text Key: 174391840
• Report Number: 1216677-2019-00296
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K963653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,user fac
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other