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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER REVOLUTION DSP FORCEPS; FORCEPS, OPHTHALMIC
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ALCON GRIESHABER AG GRIESHABER REVOLUTION DSP FORCEPS; FORCEPS, OPHTHALMIC Back to Search Results
Catalog Number 706.44
Medical Device Problem Code Difficult to Open or Close (2921)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No sample or lot number information has been received at manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A physician reported that multiple forceps failed to actuate properly during separate vitrectomy procedures.Another forceps was opened in each event and the surgery was completed.There was no patient harm.
 
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Brand Name
GRIESHABER REVOLUTION DSP FORCEPS
Common Device Name
FORCEPS, OPHTHALMIC
Manufacturer (Section D)
ALCON GRIESHABER AG
winkelriedstrasse 52
schaffhausen 8203
SZ  8203
MDR Report Key12335536
Report Number3003398873-2021-00055
Device Sequence Number4425300
Product Code HNR
UDI-Device Identifier07612717066960
UDI-Public07612717066960
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/18/2021
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
Operator of Device Health Professional
Device Catalogue Number706.44
Device Lot NumberASKU
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/21/2021
Initial Report FDA Received Date08/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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