MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. KITTNER; DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	28-0801
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call 47644) was received for a kittner dissector (part 28-0801, lot 49522547) that failed during a procedure.The cotton tip separated from the dissector while in use in a patient.A sample was returned for evaluation.The investigation is ongoing at this time.When new information is received, this report will be updated.
Event or Problem Description
Small delay with procedure getting a new kittner tip.The entire gauze tip came off of the end of the dissector while in use in the patient.
Additional Manufacturer Narrative
Root cause: the raw material is supplied to deroyal by medsorb dominicana.Therefore, a supplier corrective action request was issued to medsorb.In its response, medsorb stated the root cause is believed to be an isolated anomaly.No evidence was found that a failure occurred during device manufacturing.All parts within the lot passed a 100 percent automated tip retention check.Corrective action: in its scar response, medsorb stated production personnel have been notified and will continue to closely monitor the situation.If any additional defects are found, the investigation will be reopened.Investigation summary an internal complaint (call 47644) was received for a kittner dissector (part 28-0801, lot 49522547) that failed during a procedure.The cotton tip separated from the dissector while in use in a patient.A sample was returned for evaluation.This was not the actual defective device but a box of unopened representative samples matching the lot number reported in the complaint.A review of the device history record showed no discrepancies that would have contributed to the reported issue.A check of raw material at deroyal's manufacturing plant showed no discrepancies in the stock on hand.The raw material is supplied to deroyal by medsorb dominicana.Therefore, a supplier corrective action request (scar) was issued to medsorb.A response was received and accepted september 13, 2019 by deroyal personnel.Deroyal has sold 11,439 cases of 28-0801 from july 2017 to present.During the same period, a total of three complaints were received for this part number, which equates to a complaint-to-sales ratio of 0.0002 or 0.026 percent.Deroyal will continue to monitor post-market feedback and will recognize in the future if a trend develops.The investigation is complete at this time.If new information is received, this report will be updated.
Event or Problem Description
Small delay with procedure getting a new kittner tip.The entire gauze tip came off of the end of the dissector while in use in the patient.

• Brand Name: KITTNER
• Common Device Name: DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial; san pedro de macoris; san pedro de macori, ; DR
• MDR Report Key: 8883374
• Report Number: 2320762-2019-00004
• Device Sequence Number: 18911749
• Product Code: GDI
• UDI-Device Identifier: 50749756025350
• UDI-Public: 50749756025350
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 28-0801
• Device Lot Number: 49522547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1