MAUDE Adverse Event Report: CAREFUSION, INC SCISSORS INSERT, MINI METZ, 36CM, 10/BOX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SP8302
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).18oct2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Event or Problem Description
Per complaint details received: it was reported that tip of scissor broke within the patient.Patient is fine.It took nearly two hours to retrieve broken piece.Incident was reported to fda by the customer.22oct2021 additional information: what was the procedure that was being performed? laparoscopic appendectomy did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? yes, the bottom blade broke off and fell into the patient and was retrieved with laparoscopy.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes, three flat plate abdominal x-rays were taken with the blade identified in each view.What was the patient¿s outcome? no obvious enterotomy or injury from the fractured piece was noted.The patient was awakened and returned to the recovery room in stable condition.Was the procedure completed as planned? intraabdominal fracture of the laparoscopic scissors extended the procedure time 1 1/2 to 2 hours.After the fractured piece was located and removed, the procedure was completed as planned.Can you please send all parts of the instrument for evaluation? yes.Do you have the lot number? yes, lot # 72892.Do you have photos of the reported issue on the instrument? yes, photos and x-rays what is the address the instrument will be returning from? (b)(6).No further information available.
Event or Problem Description
Per complaint details received: it was reported that tip of scissor broke within the patient.Patient is fine.It took nearly two hours to retrieve broken piece.Incident was reported to fda by the customer.(b)(6) 2021 additional information: what was the procedure that was being performed? laparoscopic appendectomy did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? yes, the bottom blade broke off and fell into the patient and was retrieved with laparoscopy.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes, three flat plate abdominal x-rays were taken with the blade identified in each view.What was the patient¿s outcome? no obvious enterotomy or injury from the fractured piece was noted.The patient was awakened and returned to the recovery room in stable condition.Was the procedure completed as planned? intraabdominal fracture of the laparoscopic scissors extended the procedure time 1 1/2 to 2 hours.After the fractured piece was located and removed, the procedure was completed as planned.Can you please send all parts of the instrument for evaluation? yes do you have the lot number? yes, lot # 72892 do you have photos of the reported issue on the instrument? yes, photos and x-rays what is the address the instrument will be returning from? tcrhcc 167 north main street tuba city, az 86045 no further information available.
Additional Manufacturer Narrative
Follow up 3781237 the complaint product was not returned, so an evaluation was performed based on the information provided.The root cause of the issue is undetermined.No customer images were provided by the customer to review.The supplier only received a description of the incident, in which the bottom blade broke at the tip.The bottom blade in the m2367 assembly is m2366.There are no retains kept in the manufacturing process.The suspect lot notified was m2367 lot 72892.Shop order 72892 manufactured 2000 devices between 3/31/2021 and 4/15/2021.The dhr for lot 72982 was reviewed for pip data and reported scrap rate.M2365 ¿ so 72395 and m2366 ¿ so 73184 lots were issued to so 72982.There were no similar complaints received for the reported part number within the last twelve months.After a review/investigation of the information provided a root cause could not be determined.If a sample is returned at a later date, a root cause may be identified.The supplier has notified applicable operators and personnel of this complaint at the time of notification.Relevant parts were placed on hold within the supplier¿s erp system.The suspect parts will undergo hardness testing at an aql level for release from quality hold.The manufacturing record was reviewed as no samples were returned and there were no deviations found.Additionally, the reported scrap rate is extremely low at 3.75% (75pc/2000pc) and all pip inspections are within specification.The complaint details were evaluated, and the reported failure was not confirmed.We will continue to monitor the reported defect to verify there is no increase in trend that may warrants corrective action.There have been no issues identified with the material or manufacturing process.The product would have been manufactured and tested according to the specifications.See h10.

• Brand Name: SCISSORS INSERT, MINI METZ, 36CM, 10/BOX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12684846
• Report Number: 1423507-2021-00047
• Device Sequence Number: 13747992
• Product Code: GEI
• UDI-Device Identifier: 10885403184154
• UDI-Public: (01)10885403184154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021
• Report Date (Section F): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SP8302
• Device Catalogue Number: SP8302
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown