MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Do you have status of device for return? can you obtain the product code/ lot number?.

Event Description

It was reported that the patient underwent an unknown procedure on(b)(6) 2019 and suture was used.It was reported that the needle broke during the surgery the broken piece was retrieved from patient.A different device was used to complete the procedure.There were no adverse patient consequences reported.No additional information could be provided.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: you requested photos of device.Do you have status of device for return? can you obtain the product code/ lot number? no.

• Brand Name: SUTURE UNKNOWN
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8680513
• MDR Text Key: 147462224
• Report Number: 2210968-2019-82532
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1