MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN

Model Number 52969

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Error "2", cut in cord.Order: (b)(4).Complaint verified -replaced diaphram.1216677-2021-00139 leep system 1000 esu gen 52969 e-complaint (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 4/28/2014 under wo #162335 (52969) & 165074 (kh1000) and shipped 6/30/2014.Manufacturing record review: dhrs 162335 & 165074 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 condition.Product receipt: the complaint unit was returned on repair log (b)(4).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.Root cause: service and repair confirmed the 'error 2', which is directly related with capacitor and fuse damage.After replacing fuse 1, capacitor 16 and 17 were also replaced.The capacitors had been updated by alsa.Service and repair will replace the capacitors if the previous versions are found on a unit.As a standard approach to verify the unit functions properly the power output was checked.This unit was noted to have the power output too high which can be adjusted to specifications.The root cause for this complaint condition is not readily available.The potential root cause is normal wear and tear over time.The diaphragm was updated due to a previous unrelated finding.*correction and/or corrective action the unit was repaired, adjusted & tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.The unit was updated with a new diaphragm and tested to specifications before returned to the customer.Corrective actions related to the diaphragm: sustaining engineering has successfully tested a replacement material made of silicone for use in repairs going forward.The ifu was also updated to add a safety check via (b)(4), p/n (b)(6).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.Correction activity in 2016.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Error "2", cut in cord.Oder: (b)(4) complaint verified -replaced diaphgram.1216677-2021-00139.Leep system 1000 esu gen 52969 (b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN
• Type of Device: LEEP SYSTEM 1000 ESU GEN
• 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: 12086285
• MDR Text Key: 261687690
• Report Number: 1216677-2021-00139
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• 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