MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	705.13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Retinal Detachment (2047)
Type of Reportable Event	Serious Injury
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
In a literature report, physicians reported that the tip of an ophthalmic forceps broke during a surgery.A new forceps were used to complete the surgery.One month after the surgery, the patient reported "one large floater" in eye.A metallic object was noted inferiorly along with a superotemporal retinal detachment.The metallic object was identified as the missing forceps tip and was removed through an enlarged sclerotomy.The retinal detachment was repaired.
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.10.No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.Sample evaluation based on paper and video analysis: - retinal detachment: as per paper the most likely root cause for the retinal detachment is user error due to insertion of another forceps.- h-intervention to preclude permanent impairment or damage: the malfunction can be confirmed, as the video and paper clearly show the removal of the foreign object (i.E., broken forceps arm).- product broken: even though the first video is not clear, due to the removal of the forceps arm it can be confirmed the product was broken during the first surgery.Most likely root cause: the initial breakage most likely occurred due to user error (i.E., opening the forceps during retrieval).This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13978819
• Report Number: 3003398873-2022-00017
• Device Sequence Number: 5567622
• Product Code: HNR
• UDI-Device Identifier: 07612717070714
• UDI-Public: 07612717070714
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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 Catalogue Number: 705.13
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male