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

Model Number LP-20-120

Device Problems Energy Output Problem (1431); Noise, Audible (3273)

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

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report forwarded by csi repair & service- "while using leep on patient, machine made strange sound and kept switching from rf on to rf leakage.Energy was not working properly.Procedure took longer than normal, she was using a roller ball on coag+ blend setting when this happened.(b)(4).Leep precision generator lp-20-120 (b)(4).

Manufacturer Narrative

Investigation: x -review dhr.X -inspect returned samples.Analysis and findings: complaint#: (b)(4).Distribution history: this complaint unit was manufactured at csi on 11/04/2015 under wo#'s (b)(4) and shipped on 12/14/2015.Manufacturing record review: dhr's (b)(4) were reviewed and no non-conformities, related 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 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 a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause : the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.Was the complaint confirmed? no.Correction and/or corrective action: none.Reason: no further training required at this time.The complaint was not confirmed to have a functional defect.However, the board was removed and set aside for additional evaluation by engineering.As a precaution, the complaint unit was fitted with a new board, tested to specifications and returned to the customer.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report forwarded by csi repair & service- "while using leep on patient, machine made strange sound and kept switching from rf on to rf leakage.Energy was not working properly.Procedure took longer than normal, she was using a roller ball on coag+ blend setting when this happened.Repair order#: (b)(4).Leep precision generator lp-20-120 (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: 10284735
• MDR Text Key: 203866309
• Report Number: 1216677-2020-00149
• 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
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other