MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP CERVIEW LAT WALL RET

Model Number	F410
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported conditon.
Event or Problem Description
Per details reported on incoming (b)(4): "on one side of both retractors there looks to be coating missing." (b)(4).
Event or Problem Description
Per details reported on incoming e-complaint (b)(4): "on one side of both retractors there looks to be coating missing." 1216677-2023-00038 leep cerview lat wall ret f410 e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation x-review dhr x-inspect returned samples.Analysis and findings complaint (b)(4).Was the complaint confirmed? no.Distribution history: the complaint product was manufactured at csi on 28-jan-2023 under work order (b)(4) and sold on 30-jan-2023.Manufacturing record review: dhr-330313 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-f410-01, workorder (b)(4) , was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint product (f410 2 pieces) were returned on 02-mar-2023 on rma number (b)(4).The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed no physical damage.The coating was applied correctly, there was no missing coating.Functional evaluation: complaint product was functionally evaluated and found to function properly.The units were hipot tested per gynce-002 and were found acceptable.Root cause: root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action 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 or Problem Description
Per details reported on incoming (b)(4): "on one side of both retractors there looks to be coating missing." 1216677-2023-00038 leep cerview lat wall ret f410 (b)(4).
Additional Manufacturer Narrative
Investigation: x-review dhr: x-inspect returned samples.*analysis and findings complaint (b)(4).*was the complaint confirmed? no distribution history: the complaint product was manufactured at csi on 28-jan-2023 under work order (b)(4) and sold on 30-jan-2023.Manufacturing record review:was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-f410-01, workorder 322990, was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint product (f410 2 pieces) were returned on 02-mar-2023 on rma number 342650.The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed no physical damage.The coating was applied correctly, there was no missing coating.Functional evaluation: complaint product was functionally evaluated and found to function properly.The units were hipot tested per gynce-002 and were found acceptable.Root cause: root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action 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.

• Brand Name: LEEP CERVIEW LAT WALL RET
• Common Device Name: LEEP CERVIEW LAT WALL RET
• 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 dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16436744
• Report Number: 1216677-2023-00038
• Device Sequence Number: 3151115
• Product Code: HGI
• UDI-Device Identifier: 00888937016222
• UDI-Public: 888937016222
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: F410
• Device Catalogue Number: F410
• Device Lot Number: 2209136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023; 02/03/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/25/2023; 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown