MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI- HARRIS UTERINE MANI

Model Number 6001

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Uf/importer report number - (b)(4).Event date (b)(6) 2016.Title: xxxxx.Event desc : the patient underwent a laparoscopic salpingo-oophorectomy.At the end of the case , the surgeon removed the humi uterine manipulator and said "look at this thing, it is bent." the humi manipulator was bent , but it was intact.(b)(4).

Manufacturer Narrative

Ref.E-complaint -(b)(4).Investigation, x-initiated manufacturer's investigation, x-no sample returned, review dhr, inspect returned samples, inspect stock product.Analysis and findings: the reported event of the end user complaining of the humi-harris having bent during use cannot be addressed as the affected device was not returned at the time of this investigation.However, if the affected device is returned in the future, the complaint may be reopened and addressed as needed.The humi-harris uterine manipulator is manufactured by an oem for (b)(4).Without knowing how much force was applied to the device or what part of the device was affected a full analysis is not possible.It may be possible that the device was used in a contraindicated manner per the device dfu.A review of the product two year complaint history, it indicated that there have other reported event that similar in nature while using the overall reported nonconforming state of the device as "broken".The device incorporates a reinforcement rib or handle in which the tube is snapped into, however, if the outer handle is dislodged the allowable max load may be compromised.Corrective actions: correction and/or corrective action.It's recommended that r&d and or sustaining engineering perform destructive device testing for the purpose of evaluating the max allowable applied pressure(s).Corrective action level 3, 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) complaint closure letter required? ncmr issued? #: capa required? #: other regulatory action needed: preventative action activity reviewed.Trend and monitor to cip.

Event Description

(b)(4).Event date (b)(6) 2016.Title: xxxxx.Event desc: the patient underwent a laparoscopic salpingo-oophorectomy.At the end of the case, the surgeon removed the humi uterine manipulator and said "look at this thing, it is bent." the humi manipulator was bent , but it was intact.Reference e-complalint number: (b)(4).

Manufacturer Narrative

Ref.E-complaint -(b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned, review dhr, inspect returned samples, inspect stock product.*analysis and findings: the reported event of the end user complaining of the humi-harris having bent during use cannot be addressed as the affected device was not returned at the time of this investigation.However, if the affected device is returned in the future, the complaint may be reopened and addressed as needed.The humi-harris uterine manipulator is manufactured by an oem for csi trumbull.Without knowing how much force was applied to the device or what part of the device was affected a full analysis is not possible.It may be possible that the device was used in a contraindicated manner per the device dfu.A review of the product two year complaint history, it indicated that there have other reported event that similar in nature while using the overall reported nonconforming state of the device as "broken".The device incorporates a reinforcement rib or handle in which the tube is snapped into, however, if the outer handle is dislodged the allowable max load may be compromised.Corrective actions: *correction and/or corrective action.It's recommended that r&d and or sustaining engineering perform destructive device testing for the purpose of evaluating the max allowable applied pressure(s).*corrective action level 3, train personnel, x-none, reason: per (b)(4), 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), complaint closure letter required? , ncmr issued? #: , capa required? #:, other regulatory action needed:.*preventative action activity reviewed.Trend and monitor to cip.

Event Description

Uf/importer report number - (b)(4).Event date: (b)(6) 2016.Title: xxxxx, event desc : the patient underwent a laparoscopic salpingo-oophorectomy.At the end of the case , the surgeon removed the humi uterine manipulator and said "look at this thing, it is bent." the humi manipulator was bent , but it was intact.Reference e-complaint number : (b)(4).

• Brand Name: HUMI- HARRIS UTERINE MANI
• Type of Device: HUMI- HARRIS UTERINE MANI
• 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: 6131884
• MDR Text Key: 61309703
• Report Number: 1216677-2016-00068
• Device Sequence Number: 1
• Product Code: KNA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 189120
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/09/2017; 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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