MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BIPOLAR FORCEPS WITH MACRO JAW; .

Catalog Number EBF01

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/01/2009

Event Type  Death  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no further informatiio has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

Received notice of a lawsuit about an incident that happened years ago, back in 2009 at university hospital of (b)(6) ((b)(6)).In 2009 (specific date is not defined), a female patient underwent a surgery at the hospital and after several post-surgery implications, the patient died.During the operation, the ees bipolar forceps endopath-ebf01 was one of the devices that were used.No further information is known, nor which device (if any) caused the death.

Manufacturer Narrative

(b)(4).On (b)(6) 2009, a female patient underwent a laparoscopic diagnostic surgery, performed at ob/gyn dept.Of (b)(6).After the surgery, the patient died due to cerebral edema received information from counsel regarding this event.It was reported by other surgeons in the hospital, the patient expired post-operatively due to cerebral edema.It is not confirmed that the ebf01 was used in the case as the records from the surgery have been deleted; however, the lead surgeon indicates this device was used.There is no information as to how the device may be linked to the patient outcome.Inquired as to whether more details of the surgery can be obtained.

• Brand Name: BIPOLAR FORCEPS WITH MACRO JAW
• Type of Device: .
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5701216
• MDR Text Key: 46622766
• Report Number: 3005075853-2016-03165
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K904993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EBF01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2016
• 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): Death