MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SATIN R-PEAN FCPS 9 CVD; N/A

Catalog Number 106196

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the satin r-pean forceps (106-196) unlocked while clamping the placenta of newborn babies during a caesarian section causing blood to potentially spray onto nurses and doctors.There was no patient or user injury reported and no delay in case is was reported.

Manufacturer Narrative

Satin forceps (106-196) was returned in used condition with the lock able to pull apart at the lowest setting due to misalignment of the teeth.The reported complaint is confirmed.Misalignment resulted from a loosening set pin at the hinge of the handles.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: SATIN R-PEAN FCPS 9 CVD
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 11337460
• MDR Text Key: 256816547
• Report Number: 2523190-2021-00029
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 106196
• Device Lot Number: AF2005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1