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

Model Number LP-20-120

Device Problem Failure to Cut (2587)

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

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.Reference : (b)(4).

Event Description

Customer stated "will not cut".Reference repair order #: (b)(4).Ref: (b)(4).

Manufacturer Narrative

Investigation: x-review dhr.X-inspect returned samples.Analysis and findings: (b)(4).Distribution history: this complaint unit was manufactured at csi on 11/3/2016 under wo #214148 & 195875 and shipped on 12/15/2016.Manufacturing record review: dhr's 214148 & 195875 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.Product receipt: the complaint unit was received 1/14/2020.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Once opened, internal damage to the display board components, r9 & r14 was confirmed.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: initial steps have screened incoming boards starting in october 2019 under non-routine inspections.The inspection was later formalized into procedure sop 59106 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

Customer stated "will not cut".Reference repair order #93661.(b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9672751
• MDR Text Key: 191402248
• Report Number: 1216677-2020-00027
• 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: user facility
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other