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

Model Number LP-10-120

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

(b)(4).Report stated out of box failure.Tested on a vegetable (really) and worked.Did not work on a patient.Unit reset itself to "wait" it was properly plugged into a wall outlet.Additional information as follows: was there patient involvement on the reported condition? no.Was there any adverse effect as a result of reported condition? no.Was there any additional medical attention? no.Did the physician perform any extra step to complete the procedure/how did physician complete the procedure.No.Was there any significant delay as result of the reported condition? no.Leep precision intg sys lp-10-120 (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 8/19/2020 under wo #'s 280418 & 280396 and shipped on 8/26/2020.Manufacturing record review: dhr's 280418 & 280396 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 a couple similar reported complaint conditions.Product receipt: the complaint unit was returned on rma 311412.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.However, the complaint description may indicate the unit was not connected to a desiccated line.A unit's power requirements is such that if connected to a line that supports other equipment, in use at the same time, it can reset as if powered off due to power cycle interruptions.*correction and/or corrective action the customer received a whole new system and an in-service was requested for this customer as well.Although the complaint was not confirmed the unit was fitted with a new main board as a precaution and converted into a demo unit.The board that was removed was set aside for additional evaluation by csi ee's.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

(b)(4).Report stated out of box failure.Tested on a vegetable (really) and worked.Did not work on a patient.Unit reset itself to "wait" it was properly plugged into a wall outlet.Additional information as follows- *was there patient involvement on the reported condition? no *was there any adverse effect as a result of reported condition? no *was there any additional medical attention? no *did the physician perform any extra step to complete the procedure/how did physician complete the procedure.No.* was there any significant delay as result of the reported condition? no.1216677-2020-00227 leep precision intg sys lp-10-120 (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
• 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: 10627849
• MDR Text Key: 218975739
• Report Number: 1216677-2020-00227
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• 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
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• 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