MAUDE Adverse Event Report: COOPERSURGICAL, INC. ALLY UPS

Model Number AU-UPS

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported condition.

Event Description

Initially, i used a 2.O loop for the procedure and the setting was 58; it was with that initial cut that the copious bleeding to the cervix was noted.As a top-hat, i used a 1.O loop and it was set on 60 however that cut did not have more bleeding than usual.The rollerball setting was 60 watts however that is the setting that is recommended on the attachment on the machine at renaissance for the rollerball.The copious amount of bleeding started with the 2 cm loop.Not the 1 cm top-hat loop.E-complaint: (b)(4).

Event Description

*corrected event description below* per report submitted by csi service and repairs- repair authorization stated" when trying to manipulate the arm, it was stuck which resulted in a bladder perforation".Unit in s & r for repair.Log# 94022 e-complaint (b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported condition.

Event Description

Corrected event description below: per report submitted by csi service and repairs.Repair authorization stated" when trying to manipulate the arm, it was stuck which resulted in a bladder perforation".Unit in s & r for repair.Log#: 94022.(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 5/9/2018 under wo#: (b)(4) and shipped on 7/9/2018.Manufacturing record review: dhr 236324 was reviewed with no failures.A move ticket was noted to have requested replacement for 3 links (p/n: 38368 lot#: 231049) that were scratching and locking.Once replaced all units on the work order passed in-process testing.The remaining links on the lot#: 231049 were segregated after inspection and scrapped (b)(4) units out.Transaction#: (b)(4).Incoming inspection review: not applicable.Service history record: this unit was here for a broken shear screw (designed to protect the device) under log 91014 on 1/15/2019 and log 92580 for locking links attributed to residue from a disinfectant on 8/8/2019.Historical complaint review: a review of the 2-year complaint history similar reported complaint condition.No other complaints were noted to have involved an injury and most were due to handling error in cleaning the links.Product receipt: the complaint unit was returned on a repair.However, based on log 94022 this unit was at csi on 3/10/2020.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.Correction and / or corrective action: the unit was fully evaluated, tested to specifications and returned to the customer.The customer was contacted for additional details but none were supplied.An in-service was offered to the customer and accepted pending changes to visitor policies.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: ALLY UPS
• Type of Device: ALLY UPS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct
• MDR Report Key: 9819927
• MDR Text Key: 191310605
• Report Number: 1216677-2020-00079
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K952483DISCO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU-UPS
• Device Catalogue Number: AU-UPS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other