MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VANTAGE SCHROEDER TENAC F; M7 - OB-GYN

Model Number	V930-965
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers: 3014334038-2022-00127 and 3014334038-2022-00128.A facility reported that the vantage schroeder tenaculum forceps (v930-965) was very stiff and clamped down hard on the patient's cervix causing bleeding.It was reported that there was no adverse consequences to the patient following the event.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The vantage schroeder tenaculum forceps were returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Visual/functional evaluation of the tenaculum forceps found that the unit was in used condition with the hinges stiff due to wear.The points were sharp and met specifications.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
N/a.

• Brand Name: VANTAGE SCHROEDER TENAC F
• Common Device Name: M7 - OB-GYN
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14766165
• Report Number: 3014334038-2022-00129
• Device Sequence Number: 16477421
• Product Code: HDC
• UDI-Device Identifier: 10381780177616
• UDI-Public: 10381780177616
• Combination Product (Y/N): N
• PMA/510(K) Number: K082349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: V930-965
• Device Catalogue Number: V930-965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown