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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER MAXGRIP ADVANCED DSP TIP FORCEPS; FORCEPS, OPHTHALMIC
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ALCON GRIESHABER AG GRIESHABER MAXGRIP ADVANCED DSP TIP FORCEPS; FORCEPS, OPHTHALMIC Back to Search Results
Catalog Number 727.13
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/22/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 a tip of forceps fell off in the eye during surgery.The dropped tip has been removed from the eye during the same procedure.The surgery was completed without product replacement.There was no patient harm.
 
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Brand Name
GRIESHABER MAXGRIP ADVANCED DSP TIP FORCEPS
Common Device Name
FORCEPS, OPHTHALMIC
Manufacturer (Section D)
ALCON GRIESHABER AG
winkelriedstrasse 52
schaffhausen 8203
SZ  8203
MDR Report Key12214182
Report Number3003398873-2021-00048
Device Sequence Number3180682
Product Code HNR
UDI-Device Identifier07612717071339
UDI-Public07612717071339
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/22/2021
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 Number727.13
Device Lot NumberASKU
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/23/2021
Initial Report FDA Received Date07/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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