MAUDE Adverse Event Report: COOPERSURGICAL, INC. UMB678 UTERINE MANIPULATOR TIP B

Model Number UMB678

Device Problems Component Falling (1105); Melted (1385)

Patient Problem No Information (3190)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint was not returned for evaluation.Once the investigation is completed a follow-up report will be filed.

Event Description

"cup melted and pieces fell into the patient during a tlh w/bs procedure." (b)(4).

Manufacturer Narrative

Ref.E-complaint -(b)(4).Investigation x-initiated manufacturer's investigation x-no sample returned x-review dhr inspect returned samples inspect stock product analysis and findings.The reported event could not be confirmed due to reported anecdotal information and absence of the affected device not being returned for analysis evaluation.It's unclear as to why the uterine manipulator was reported in the complaint when a cup is not part of the device.It's presumed that the [?]cup" being referred is a koh-cup which is a separate device.The reporting that the cup melted infers that another device such an electro-cautery scalpel may have been used at the time of the reported event.The root cause as to the occurrence of the reported event is indeterminable.Recommendation may be to follow up with the complainant for additional information or clarification of the actual event.A review of the rumi tip manufacturing line assured that all controls were in place for proper product acceptance at the time of manufacturing of identified lot, and has not been altered.A review of the lot dhr did not reveal any abnormalities; each rumi device is 100% functionally and visually verified during in-process manufacturing for documented product acceptance criteria.Corrective actions correction and/or corrective action corrective action is not applicable at this time as the reported event is considered not to have any implications on the reported event.Corrective action level 4 train personnel x-none reason: per bsr-qar-026, this complaint will be monitored for trending in that no injury was reported to end user or patient.Was the complaint confirmed? no.Review and closure x-recommended continuous improvement program (cip) capa required? complaint closure letter required? ncmr issued? other regulatory action needed: preventative action activity reviewed.Trend and monitor to cip.

Event Description

"cup melted and pieces fell into the patient during a tlh w/bs procedure".Reference e-complaint number : (b)(4).

• Brand Name: UMB678 UTERINE MANIPULATOR TIP B
• Type of Device: UMB678 UTERINE MANIPULATOR TIP B
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5614232
• MDR Text Key: 44587094
• Report Number: 1216677-2016-00009
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/16/2018
• Device Model Number: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 193115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: No
• 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