MAUDE Adverse Event Report: COOPERSURGICAL INC. MITYONE MUSHROOM CUP

Model Number 10067

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Stem snapped in the middle of vacuum extraction.Doctor tells that she didn't have to use force in pulling and even though the stem snapped.Mityone mushroom cup 10067 (b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Manufacturer Narrative

Investigation x-review dhr *analysis and findings complaint (b)(4) distribution history: this complaint unit was manufactured at csi on 11/05/2021 under wo #(b)(4) manufacturing record review: dhr 311042 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: not applicable.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was not returned.Visual evaluation: evaluation of the complaint unit could not be completed as it has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint unit could not be completed as the complaint unit 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: a root cause is not determinable.*correction and/or corrective action no applicable corrective actions as no root cause has been determined.No other units from lot #311042 are in stock for review.A review of the process confirms each unit's gauge is checked.Also, each cup is bent over where the stem meets, verifying no separation occurs.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.

Event Description

Stem snapped in the middle of vacuum extraction.Doctor tells that she didn't have to use force in pulling and even though the stem snapped.(b)(4) mityone mushroom cup 10067 (b)(4).

• Brand Name: MITYONE MUSHROOM CUP
• Type of Device: 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: 15051774
• MDR Text Key: 303852288
• Report Number: 1216677-2022-00207
• Device Sequence Number: 1
• Product Code: HDB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K890307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 311042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other