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

Model Number LP-20-120

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Event Description

E-complaint: (b)(4).Report forwarded by service & repair- unit would not coagulate and patient had to go via ambulance to emergency room.Another leep unit was used successfully to stop bleeding.Leep precision generator lp-20-120.E-complaint- (b)(4).

Event Description

(b)(4).Report forwarded by service & repair- unit would not coagulate and patient had to go via ambulance to emergency room.Another leep unit was used successfully to stop bleeding.1216677-2021-00070 leep precision generator lp-20-120 (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 10/17/2019 under wo (b)(4) and shipped on (b)(6) 2019.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: this unit was returned for unconfirmed intermittent function noted on log 95722 february 16, 2021.The unit was fitted with a new board as a precaution.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on (b)(4).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.*correction and/or corrective action the customer was provided with a new generator.The returned unit was found to function to specifications free of defects.As the inspection of this unit did not provide a confirmation of the described complaint, or any defects, this unit was sent to engineering to be further evaluated.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11665468
• MDR Text Key: 260990534
• Report Number: 1216677-2021-00070
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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: Health Professional
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other