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

Model Number LP-10-120

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Customer stated "will not coag or blend".Repair tech stated "cannot confirm complaint - replaced 2 missing bolts in integ unit" ro 96596.Leep precision intg sys lp-10-120 e-complaint- (b)(4).

Event Description

Customer stated "will not coag or blend".Repair tech stated "cannot confirm complaint - replaced 2 missing bolts in integ unit".(b)(4).Leep precision intg sys lp-10-120 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 9/21/2018 under wo's #(b)(4) and shipped on 10/29/2018.Manufacturing record review: a review of the device history 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 quality release specifications.Should the device history record be located going forward this complaint will be amended accordingly.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: 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 96596.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.The unit's integration unit was noted to have 2 screws missing but the finding is not considered related to the complaint description as the unit functioned free of issues.Correction and/or corrective action.The unit was fitted with replacement screws noted to be missing, tested to specifications and returned to the customer.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 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: 12238849
• MDR Text Key: 265986926
• Report Number: 1216677-2021-00152
• 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: 11/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: 07/07/2021
• 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