MAUDE Adverse Event Report: AESCULAP AG TC BABY-METZ SCISSORSDELCVDB/B145MM; BASIC INSTRUMENTS

Model Number BC259R

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was an issue with bc259r - tc baby- metz scissorsdelcvdb/ b145mm.According to the complaint description, the scissor broke.There was unknown patient harm.Additional details have been requested.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

Update: the scissors was broken at the screw.

Manufacturer Narrative

Additional information/correction: b5 - description update upon review of the investigation results, the complaint was re-assessed and found to be non-reportable; severity was decreased from 3 to 2 as per the product risk analysis.Investigation results: visual investigation: here we found a corrosion on the cemented carbide tip bc263200.Additionally we detected grooves.Pitting was also found.Furthermore the cutting edge was severely damaged, and the screw was not present.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: the root cause of the problem is most probably usage and reprocessing related.In this case we have more than one indication that may led to the assumption that the instrument screw was loosed and the product solved in two parts.The reason for the error is due to that the wrong preparation and the lack of oiling caused the user to overuse the instrument, which resulted in the scissors being severely damaged in the running surfaces and on the cutting edge.As announced the grooves at the male box-lock could have caused due to an insufficient lubrication or foreign bodies.Additionally it could be that the discoloration are pinprick-like corrosion holes surrounded by sparkling, reddish-brown or multi-colored corrosion spots, often associated with circular corrosion deposits around the corrosion hole.The following points could be the cause of this: - exposure due to halide ions (bromides, iodides and chlorides) but especially chlorides that locally break through the passive layer of instrument steel thus causing pitting - dried-on organic residues, e.G.Blood, pus, secretions - frequent pitting is due to the use of liquids with high chloride content or more specifically due to dry residues of such liquids adhering to the instrument surfaces, e.G.If the concentration of chlorides in the final rinse water is too high or if residues of physiological salt solutions remain on the instruments.- brand new instruments are particularly susceptible to attack by media containing chlorides due to their still thin passive layer.Instruments that have been use for some time are more resistant to chloride attack because they have developed a thicker passive layer.If this occur the corrosion products can be dissolved with an acid-based detergent used in accordance with the manufacture's instruction.Some preventive measures would be largely prevented by using low-chloride water qualities, by minimizing organic residues or other effects of chloride-containing liquids, such as physiological cooking salt solution on instrument steel.Severely corroded instruments should be immediately withdrawn from service (and the instrument processing cycle) for reason of patient and user safety.To retain the value of instruments, the causes of pitting must be eliminated and corrosion holes can pose a hygienic hazard.The corrosion holes may lead to stress corrosion cracking as well.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably reprocessing- related.Based upon the investigation results, a capa is not necessary.

• Brand Name: TC BABY-METZ SCISSORSDELCVDB/B145MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15284377
• MDR Text Key: 302247928
• Report Number: 9610612-2022-00257
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BC259R
• Device Catalogue Number: BC259R
• Device Lot Number: 4512576520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1