MAUDE Adverse Event Report: COOPERSURGICAL, INC. ALLY UPS

Model Number	AU-UPS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report submitted by csi rep- incident report: sterile drape ripped during hysterectomy case and when it was removed, the ally arm was covered in patient blood and fluid.Cleaned off as much as possible with alcohol, but need to be sterilized before use on another patient".(b)(4).1216677-2020-00203 ally ups au-ups (b)(4).
Additional Manufacturer Narrative
Investigation: review dhr; inspect returned samples.Distribution history: this complaint unit was manufactured at csi on 09/17/2015 under wo # (b)(4) and last shipped on 6/12/2018.Manufacturing record review: dhr (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was in for unrelated service repairs.The last return in 7/23/2020 under log 94622 found the goose neck required a minor adjustment on the tension in the flaccid state.It was also noted to have been damaged and repaired.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.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 device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.This unit functioned free of defects displaying no malfunctions.Exposure to fluids is the result of the drape being compromised either by end user handling or had been damaged when prepped and not noticed till later.The drape is a disposable product and discarded by the customer.Corrective actions a request for additional detail on the complaint was made, but no response was provided by the customer as of 9/9/2020.As this unit was noted to have been exposed to bodily fluids the links were removed and cleaned to remove any potential residue.Once cleaned the unit was fully assembled with a new cable, 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.No further training required at this time.Was the complaint confirmed? no.
Event or Problem Description
Report stated: "incident report: sterile drape ripped during hysterectomy case and when it was removed, the ally arm was covered in patient blood and fluid.Cleaned off as much as possible with alcohol, but need to be sterilized before use on another patient".Au-ups ally ups (b)(4).

• Brand Name: ALLY UPS
• Common Device Name: ALLY UPS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10508519
• Report Number: 1216677-2020-00203
• Device Sequence Number: 14243331
• Product Code: LKF
• UDI-Device Identifier: 00888937015836
• UDI-Public: 888937015836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: AU-UPS
• Device Catalogue Number: AU-UPS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 02/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown