MAUDE Adverse Event Report: ETHICON INC. SHEATH OUTER 27FR; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number	01939
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Was the broken piece retrieved? was there any patient consequence and/or surgical/medical intervention?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2018 and the electrosurgical device was used.It was also reported that ceramic tip of the device broken.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4) date sent to the fda: (b)(4) /2018.The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Additional information was requested, and the following was obtained: -no additional information available.1.Was the broken piece retrieved? 2.Was there any patient consequence and/or surgical/medical intervention?.

• Brand Name: SHEATH OUTER 27FR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7887455
• Report Number: 2210968-2018-75886
• Device Sequence Number: 2725872
• Product Code: HIH
• UDI-Device Identifier: 10705031000964
• UDI-Public: 10705031000964
• Combination Product (Y/N): N
• PMA/510(K) Number: K040302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 01939
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/20/2018
• Patient Sequence Number: 1