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

Model Number LP-10-120

Device Problems Intermittent Continuity (1121); Failure to Cut (2587)

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

Event Date 05/09/2019

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

"per rep's telephone report- the leep stopped cutting mid procedure.Leep machine encountered short circuit , jumping between blending and coag.It was reported that leep machine encountered intermittent issues in the process of obtaining patient specimen - dr.Was unable to cut through, eventually had to switch to other means." (b)(4).

Event Description

"per rep's telephone report- the leep stopped cutting mid procedure.Leep machine encountered short circuit , jumping between blending and coag.It was reported that leep machine encountered intermittent issues in the process of obtaining patient specimen- dr.Was unable to cut through, eventually had to switch to other means." reference: (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 issues.A review of the dhr reveals no anomalies.A record of failed boards confirm 3 were pulled off the work order on the generator level, but the failures do not indicate a relation to this complaint.This unit was manufactured under wo #246376.The sub-assembly, p/n lp-20-120, was assembled under wo #248323.This unit shipped november 2018.Service & repair did not confirm the complaint condition.The evaluation was only possible on the generator as no other equipment was sent in.A root cause is not readily available for this unit.The unit was also observed to have impact damage on the front left top edge of the console.As no functional defects were noted on the device it is likely certain conditions were present at the time of the incident.This device, however, was free of defects.The device evaluation did not include the actual patient pad, the pen or the ball end.These are devices that are sold separately.It is possible, the issue encountered may center around one of these.Correction and/or corrective action: none.No applicable correction available to train to at this time.The unit was fitted with a new board, tested and returned to the customer.Additional information from the customer was requested and provided for clarification.However, the information did not provide a clear indication on the root cause.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• 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: 8621424
• MDR Text Key: 145627451
• Report Number: 1216677-2019-00084
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• 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: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other