MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER ADVANCED DSP TIP SCISSORS; SCISSORS, OPHTHALMIC

Catalog Number 725.52P

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

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 Description

A healthcare professional reported that a curved scissor tip broke off and fell into the back of a patient's eye during surgery.There was no report of any patient harm.Additional information has been requested.Additional information received further clarified that the scheduled procedure was a pars plana vitrectomy and endolaser with ophthalmic gas and oil.The broken scissor tip was successfully removed from the patient¿s eye by means of an ophthalmic forceps.An alternate scissors was obtained in order to complete the procedure.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample received.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The sample is not available for investigation, therefore, damage cannot be confirmed or rather a root cause cannot be identified.Should sample return this complaint will be reopened and the sample will be investigated.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).

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample is received with inner blister, outer blister and cover foil showing the lot information.The sample shows no macroscopic signs of damage.The sample shows signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The scissors blade is broken.The customer¿s complaint was confirmed.As the sample shows signs of surgery residues, the root cause cannot be determined conclusively.The root cause cannot be identified conclusively because the sample has pass the 100% inspection.As the sample shows signs of surgery residues, the customer has handled the product.The point in time when the malfunction occurred, can no longer be determent.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER ADVANCED DSP TIP SCISSORS
• Type of Device: SCISSORS, 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: 12853128
• MDR Text Key: 281097238
• Report Number: 3003398873-2021-00087
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 07612717070882
• UDI-Public: 07612717070882
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 725.52P
• Device Lot Number: F200908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SURGICAL PRODUCT, UNSPECIFIED
• Patient Age: 57 YR
• Patient Sex: Male