MAUDE Adverse Event Report: ETHICON INC. GYNECARE VERSASCOPE SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number GMS805

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Bleeding (1738)

Event Date 02/18/2015

Event Type  Injury  

Manufacturer Narrative

Conclusion: actual device was returned for evaluation.Visual inspection revealed the distal end of the instrument sheath was torn and deformed.Due to the condition of the device, the failure mode is inconclusive and could be user or manufacturing related.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that a patient underwent a trans-cervical polyp resection on (b)(6) 2015.As the device was inserted into the uterus, the surgeon lost view of the tip and it went off of the track and bleeding developed.There was no perforation of the uterus.The amount of bleeding is unknown.The device was removed.No additional measures were taken as a result of the bleeding.Additional information was requested.

Manufacturer Narrative

(b)(4) - device went off of the track.Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: GYNECARE VERSASCOPE SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): CONMED; 525 french road; utica NY 13502 599
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4609308
• MDR Text Key: 13499127
• Report Number: 2210968-2015-03081
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K972426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: GMS805
• Device Lot Number: 140804-805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR