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

Model Number LP-10-120

Device Problem Activation Problem (4042)

Patient Problems Failure to Anastomose (1028); Blood Loss (2597)

Event Date 11/02/2018

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

"during a leep procedure the physician made a blended cut into the cervix, after the sample of tissue was removed successfully, the physician used the ball electrode to attempt to coagulate the bleeding.The coagulation function would not work on the machine.They increased the wattage and attempted to coagulate again and still did not work.The assistant got a new leep pencil and ball electrode and attempted to coagulate again and it still did not work.At this point the physician had to apply pressure to stop the bleeding enough to suture the patients cervix and after 45 minutes they were able to stop the bleeding and stabilize the patient.Patient was awake for the entire procedure.This generator had been previously sent in for repairs for failure to function properly using the coagulation mode.Customer does not want this same generator back, wants replacement, does not trust it anymore.Needs the generator sent next day for cases on tuesday." (b)(4).

Manufacturer Narrative

Ref e-complaint(b)(4).Investigation: x-review dhr, x-inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.This unit was manufactured under wo #221505.The sub-assembly, p/n lp-20-120, was assembled under wo #(b)(4).A review of the sub-assembly p/n noted this unit was re-fitted with a second board (p/n 300788-r).The unit was confirmed to have passed all in-process testing thereafter.The complaint condition was not confirmed.The unit's power output was within specifications.The unit was noted to have been checked previously (log 89478).Nothing was found or confirmed then either.To remove any doubt, a new board was used to replace the board in the device, tested successfully, and returned to the customer.There is no definitive root cause for this complaint condition.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 and no duplication of the device was possible.The device evaluation did not include the actual patient pad, the pen or the ball end.These are devices that are separately sold.It is possible, the issue encountered centers around one of these as well.Also, it is possible the patient pad connection was compromised.If no connection is present, the device will not provide power to the pen.This is by design to prevent injury.Without a patient pad connection there is no path to ground.The device does have a light indicator were this condition to manifest during a procedure.It lights up next to text "patient pad loose".Correction and/or corrective action: the customer was sent a new replacement unit while the returned device was converted into a demo.This complaint will be entered into the coopersurgical continuous improvement plan (cip).No applicable correction available to train to at this time.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"during a leep procedure the physician made a blended cut into the cervix, after the sample of tissue was removed successfully, the physician used the ball electrode to attempt to coagulate the bleeding.The coagulation function would not work on the machine.They increased the wattage and attempted to coagulate again and still did not work.The assistant got a new leep pencil and ball electrode and attempted to coagulate again and it still did not work.At this point the physician had to apply pressure to stop the bleeding enough to suture the patients cervix and after 45 minutes they were able to stop the bleeding and stabilize the patient.Patient was awake for the entire procedure.This generator had been previously sent in for repairs for failure to function properly using the coagulation mode.Customer does not want this same generator back, wants replacement, does not trust it anymore.Needs the generator sent next day for cases on tuesday." e-complaint(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: 8085552
• MDR Text Key: 128044144
• Report Number: 1216677-2018-00069
• 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: 12/27/2019

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-10-120
• Device Catalogue Number: LP-10-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other