MAUDE Adverse Event Report: AESCULAP AG TC HEGAR NEEDLE HOLDER HVY- SERR240MM; NEEDLE HOLDER, REUSABLE

Model Number BM078R

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "the carbide insert cracked during use.The failure occurred during a gynecology procedure.Post-operative x-ray examination showed no sign of foreign object in the patient's body." it was noted as the first use of the device.Additional patient information has been requested.When additional information is received a follow up report will be submitted.

• Brand Name: TC HEGAR NEEDLE HOLDER HVY- SERR240MM
• Type of Device: NEEDLE HOLDER, REUSABLE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8267641
• MDR Text Key: 133750075
• Report Number: 9610612-2019-00037
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BM078R
• Device Catalogue Number: BM078R
• Device Lot Number: 4509599999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/16/2019
• Device Age: 6 MO
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention