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

Model Number	10067
Health Effect - Clinical Codes	Fetal Distress (1856); Hemorrhage, Subgaleal (2603)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report submitted by (b)(6) in ref.To letter no.(b)(4).Item-disposable vaccum delivery system.We are receiving more feedbacks from end users in (b)(6) hospital for the above item as follows: the pressure is not building up due to which a second cup has to be opened immediately.This has occurred multiple times.According to the pediatricians, sub galeal hemorrhages & fetal distress episodes have increased.01/27.2021- follow-up response requesting other incidents stated."further to your mail we had a meeting today with the end users of rustaq hospital sultanate of oman.Unfortunately, they don't keep any track record for the failed vacuum deliveries and since they have discarded the affected pieces after use, we are unable to send the samples back to your facility for the further investigations." mityone mushroom cup 10067 e-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned review dhr *analysis and findings distribution history the complaint products were manufactured at csi.Manufacturing record review dhr-10067 - 271730 was reviewed and no abnormalities were noted.All vacuum testing was accepted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt the complaint product was not returned to csi.Visual evaluation a physical device evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation an evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.*was the complaint confirmed? no.
Event or Problem Description
We are receiving more feedbacks from end users in (b)(6) hospital for the above item as follows: -the pressure is not building up due to which a second cup has to be opened immediately.This has occurred multiple times.-according to the pediatricians, sub galeal hemorrhages & fetal distress episodes have increased.Follow-up: "further to your mail we had a meeting today with the end users of (b)(6) hospital sultanate of oman.Unfortunately, they don't keep any track record for the failed vacuum deliveries and since they have discarded the affected pieces after use, we are unable to send the samples back to your facility for the further investigations." 1216677-2021-00015-1 mityone mushroom cup 10067 (b)(4).

• Brand Name: MITYONE MUSHROOM CUP
• Common Device Name: MITYONE MUSHROOM 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: 11336651
• Report Number: 1216677-2021-00015
• Device Sequence Number: 3781989
• Product Code: HDB
• UDI-Device Identifier: 00888937003123
• UDI-Public: 888937003123
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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): 02/15/2023

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: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 271730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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