MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 - 110V

Model Number L1000

Device Problems Energy Output Problem (1431); Failure to Cut (2587)

Patient Problem Alteration In Body Temperature (2682)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Customer stated "on 50 watts of blend, the loops, especially the wider ones, are dragging so much through the tissue that it is not even cutting or cauterizing" reference repair order # (b)(4).(b)(4).

Event Description

Customer stated "on 50 watts of blend, the loops, especially the wider ones, are dragging so much through the tissue that it is not even cutting or cauterizing".Reference repair order #(b)(4).(b)(4).

Manufacturer Narrative

Ref: (b)(4).Investigation : x-inspect returned samples.Analysis and findings: distribution history: this complaint unit was manufactured at csi on 4/1/1998 under wo #(b)(4) and shipped on 4/23/1998.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Subsequently (after being returned), this unit was damaged and returned again for physical impact damage.It was repaired under log (b)(4).Unit was dropped but no damage was noted on outer box.Historical complaint review: a review of the attached 2-year complaint history showed one similar reported complaint condition.The description of dragging was in reference to the 'cut' mode, not blend.Product receipt: the complaint unit was returned on a repair.However, based on log (b)(4), this unit was at csi on 6/11/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit's output was below specifications.Root cause : the root cause of this issue has been attributed to wear and tear.Although not related to the complaint, or faulty on this unit, the diaphragm required an update.Due to the potential for degraded latex films any unit found to have an outdated diaphragm is changed out for a new one.Corrective actions correction and/or corrective action the unit's output was adjusted, tested to specifications and returned to the customer at a charge.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.Diaphragm related correction: coopersurgical service & repair team replaced the diaphragm on the unit and returned it to the customer.Sustaining engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.No further training required at this time.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: LEEP SYSTEM 1000 - 110V
• Type of Device: LEEP SYSTEM 1000
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8884617
• MDR Text Key: 154171226
• Report Number: 1216677-2019-00226
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K952483
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L1000
• Device Catalogue Number: L1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other