MAUDE Adverse Event Report: COOPERSURGICAL, INC. ORANG UTERINE MANIPULATOR

Model Number UMO672

Device Problems Break (1069); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

Report stated "product broke during using, experienced tech heard a pop "product felt broken" and insulation was lost- product removed, uterus removed via other means- patient injury unknown-surgery continued completed using other means.

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Report stated "product broke during using, expirienced tech heard a pop "product felt broken" and insuflation was lost- product removed, uterus removed via other means- patient injury unknown-surgery continued completed using other means.1216677-2022-00101-1 orang uterine manipulator umo672 e-complaint(b)(4).

Manufacturer Narrative

Investigation.Review dhr.Inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 05/27/2020 under wo # (b)(4) and shipped on 08/13/2020.Manufacturing record review: dhr-282264 was reviewed and no non-conformities, related to the complaint condition, were noted.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 did not show similar reported complaint conditions.Product receipt: the complaint product umo672 1 piece was returned open on 04/22/2022.The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: complaint product was functionally evaluated and found to function properly.The balloon was inflated with 5cc of air and held the air.See attached picture.This lot number has been depleted from fg.Root cause: root cause not applicable as the complaint condition was not confirmed.Corrective actions.The complaint condition was not confirmed, coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.*was the complaint confirmed? no.

• Brand Name: ORANG UTERINE MANIPULATOR
• Type of Device: ORANG UTERINE MANIPULATOR
• 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: 13966239
• MDR Text Key: 294406079
• Report Number: 1216677-2022-00101
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932115
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: UMO672
• Device Catalogue Number: UMO672
• Device Lot Number: 282264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other