MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD UNKNOWN FORCEPS; N/A

Catalog Number XXX-FORCEPS

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The following information was received via canada vigilance - medical device problem reporting program / reference number (b)(4): it was reported that the patient was receiving a caesarian section.Green-armytage forceps was used to close the uterus when one of the distal arms of the forceps snapped off completely and fell into the uterine cavity.The uterus was reopened and the metal part was retrieved and all parts of the forceps was accounted for.

Manufacturer Narrative

A follow-up was made to obtain additional information from the initial reporter and end-users.As per hospital staff, no one was aware as to why the report was sent to integra from health canada.It was noted that the hospital had previously purchased the suspected green armytage forceps and crile forceps from integra, teleflex and amt; therefore, the suspected product may not be an integra product.After careful review of our system, integra could not locate products with reported device id 811300.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

The reported crile hemostatic forceps (811300) was not returned for evaluation and lot number information has not been provided; therefore, an investigation of the device could not be performed.The reported product id does not match any integra product; thus, manufacturing records could not be reviewed.The device's identity and manufacturer is unknown, and the product is not available for return.Definitive root cause cannot be determined.The issue snapping during use may be the result of rough handling or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNKNOWN FORCEPS
• Type of Device: N/A
• 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: 15539936
• MDR Text Key: 301160645
• Report Number: 3014334038-2022-00220
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-FORCEPS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female