MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

Model Number LP-10-120

Device Problem Failure to Power Up (1476)

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

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint will be returned by the customer and evaluated.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Machine doesn't always turn on.Reference e-complaint: (b)(4).

Manufacturer Narrative

Ref: (b)(4).Investigation: x-review dhr.X-inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals similar issue.A review of the dhr reveals no anomalies.Service & repair did not confirm the complaint.The unit functioned with no functional issues.The complaint description is vague and does not specify which mode was not functioning or if all modes were not working.It indicated there was an intermittent issue with the unit turning on which was not confirmed.There is no root cause for this complaint condition.It is highly likely the end user was not properly operating the device.This unit is on recall 1216677-05-24-2019-002-r for the potential to have an overloaded c21 due to excessive current above the capacitors' rating.This failure is specifically for loss of foot pedal function.A device can still produce an output using a hand piece.The correction applied to a unit is on the main display portion of the board by installing a diode on c21.This unit was not returned for a foot pedal failure nor did it exhibit this failure upon evaluation.Correction and/or corrective action: the unit was returned to the customer after the board was updated.A recommendation to have an in-service visit made on this customer was sent to both marketing and product surveillance to provide guidance as needed.The unit was noted to be on the recall list and subsequently processed for re-work under wo #273866 to add the diode to c21 and test.Upon completion the unit was processed for a return to the same customer.Capa 725 was issued and a recall (1216677-05-24-2019-002-r) will address the remaining units from the implementation of the rohs board into production up to the addition of the zener diode under ecn-21881.Was the complaint confirmed? no.

Event Description

Machine doesn't always turn on.Reference: (b)(4).

• Brand Name: LEEP PRECISION INTG. SYS.
• Type of Device: LEEP PRECISION INTG. SYS.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• MDR Report Key: 8792607
• MDR Text Key: 151298048
• Report Number: 1216677-2019-00200
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other