MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYONE BELL CUP

Model Number	10068
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
E-complaint: (b)(4).Incident details surrounding event: during the procedure, the pump cannot reach 40cmhg.Update- the nurse responded to follow-up question as follows- any significant delay as a result of the reported condition? there was probably a couple of contractions delay - so about 3-5 minutes.Did the physician perform any extra step to complete the procedure.How was the procedure completed? the ob requested to bring forceps.In the end, the birth was complete with reapplication - minimal suction' pressure - not even the green zone and coached maternal increased effort with.The pop-off would happen with the regular pull, but the minimal pull and maternal push over a few more contractions (with pop offs) brought the fetal head down and then the ob was able to complete the delivery.Mityone bell cup 10068.E-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples.*analysis and findings (b)(4).Distribution history: this complaint unit was manufactured at csi on 11/25/2019 under wo #(b)(4) and shipped on (b)(6) 2007.Manufacturing record review: dhr 273733 was 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 no similar reported complaint condition.Product receipt: the unit was received in under rma #(b)(4) on 04/01/2021.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 specifications.Root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action the unit was discarded.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
During the procedure, the pump cannot reach 40cmhg.1.Any significant delay as a result of the reported condition? there was probably a couple of contractions delay - so about 3-5 minutes.2.Did the physician perform any extra step to complete the procedure / how was the procedure completed? the ob requested to bring forceps.In the end, the birth was complete with reapplication - minimal suction pressure - not even the green zone and coached maternal increased effort with.The pop-off would happen with the regular pull, but the minimal pull and maternal push over a few more contractions (with pop offs) brought the fetal head down and then the ob was able to complete the delivery.Mityone bell cup 10068 (b)(4).

• Brand Name: MITYONE BELL CUP
• Common Device Name: MITYONE BELL CUP
• 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: 11651659
• Report Number: 1216677-2021-00066
• Device Sequence Number: 16971322
• Product Code: HDB
• UDI-Device Identifier: 00888937003130
• UDI-Public: 888937003130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K890307
• 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
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10068
• Device Catalogue Number: 10068
• Device Lot Number: 271733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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